Drugs / cyclobenzaprine
cyclobenzaprine
also known as
TNX-102 SL · cyclobenzaprine hydrochloride · Cyclobenzaprine HCl · Flexeril · TNX-102 · AMRIX · cyclobenzaprine hydrochloride is Amrix 15mg/daily · Miosan · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FLEXERIL | — | 2003-02-03 | fda.gov ↗ |
| Approved | US (FDA) | FLEXERIL | — | 1977-08-26 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07413367 | Dec 2025 → Feb 2026 overdue | — | Tonix Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07464535 | Mar → Apr 2022 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03443960 | Jan → Apr 2018 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03353922 | Jul → Dec 2017 | — | Neurana Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01689259 | Sep 2012 → Dec 2013 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01634412 | Jun 2012 → Sep 2013 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01490788 | Nov → Dec 2011 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00913419 | Nov → Dec 1988 | depressive disorder | Sandoz | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06636786 | Mar 2025 → Sep 2026 overdue | acute stress disorder, cognitive disorder, post-traumatic stress disorder | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 2 | NCT05372887 | Oct → Nov 2022 | post-traumatic stress disorder | Tonix Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01921296 | Aug 2013 → May 2014 | sleep disorder, initiating and maintaining sleep | Lynn Henry | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07404397 | Feb → Dec 2026 expected | anismus | University of Michigan | Recruiting | No outcome recorded |
| Phase 39 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT05683574 | May 2026 → Oct 2027 | — | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04172831 | Dec 2019 → Oct 2020 | fibromyalgia | Tonix Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT03841773 | Mar 2019 → Apr 2020 | post-traumatic stress disorder | Tonix Pharmaceuticals, Inc. | Terminated | Missed primary |
| Phase 3 | NCT03508700 | Apr 2018 → Sep 2019 | post-traumatic stress disorder | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03062540 | Mar 2017 → Jul 2018 | post-traumatic stress disorder | Tonix Pharmaceuticals, Inc. | Terminated | Missed primary |
| Phase 3 | NCT02814565 | Oct 2016 → Feb 2017 | — | Takeda | Completed | Missed primary |
| Phase 3 | NCT02829814 | Jul → Sep 2016 | fibromyalgia, myofascial pain syndrome, neuromuscular disease, rheumatic disorder | Tonix Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02436096 | Apr 2015 → Sep 2016 | fibromyalgia, myofascial pain syndrome, neuromuscular disease, rheumatic disorder | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01421433 | May → Aug 2012 | — | Farmoquimica S.A. | Unknown | No outcome recorded |
| Phase 44 trials · 2 missed | ||||||
| Phase 4 | NCT07840183 | Sep 2026 → Sep 2027 expected | — | Northwestern University | Recruiting | No outcome recorded |
| Phase 4 | NCT07664956 | Jul → Sep 2026 overdue | adenomyosis, chronic pain syndrome, endometriosis, endometritis +2 | Christiana Care Health Services | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT01041495 | Jun 2009 → Mar 2013 | fibromyalgia | State University of New York - Upstate Medical University | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT00246389 | ? → Jul 2004 | — | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | Completed | Missed primary |
| Phase not applicable2 trials | ||||||
| — | NCT01081990 | Apr 2010 → Jul 2014 | — | Endeavor Health | Completed | No outcome recorded |
| — | NCT00635037 | Jun 2004 → Feb 2005 | myofascial pain syndrome | Federal University of São Paulo | Completed | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 1 | NCT04407377 Comparator | Jun → Oct 2020 | — | Neurana Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01889173 Comparator | Jun → Dec 2013 | — | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02277704 Comparator | Oct 2014 → May 2016 | post-traumatic stress disorder | Tonix Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00790270 Comparator | Jan 2003 → Jan 2004 | — | Stony Brook University | Completed | No outcome recorded |
| Phase 3 | NCT07296770 Background | Oct 2026 → Dec 2028 expected | chronic pain syndrome | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03127592 Comparator | Oct 2020 → Jul 2022 | — | Apsen Farmaceutica S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02642861 Comparator | Oct 2018 → Dec 2019 | cirrhosis of liver | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT03025113 Comparator | Mar 2018 → Nov 2019 | musculoskeletal system disorder | EMS | Completed | No outcome recorded |
| Phase 3 | NCT02862977 Comparator | Nov 2017 → Jun 2019 | musculoskeletal system disorder | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01587508 Comparator | May 2013 | — | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01151787 Comparator | Jul 2010 → Sep 2013 | migraine disorder | Kennedy Medical Group | Terminated | No outcome recorded |
| Phase 4 | NCT04990804 Background | Aug 2021 → Feb 2022 | spinal cord disorder, substance-related disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT04240626 Background | Jan 2021 → Jun 2025 | morbid obesity | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT04704297 Comparator | Dec 2020 → Jul 2022 overdue | myofascial pain syndrome | Madigan Army Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT01587274 Comparator | Apr 2012 → Oct 2014 | — | Montefiore Medical Center | Completed | No outcome recorded |
| — | NCT03119324 Comparator | Sep 2015 → Jun 2016 | temporomandibular joint disorder | University of Roma La Sapienza | Completed | No outcome recorded |
| — | NCT02974166 Background | Mar 2012 → Nov 2015 | temporomandibular joint disorder | Instituto Brasileiro de Osteopatia | Completed | No outcome recorded |
| — | NCT01028014 Comparator | Apr 2010 → Apr 2011 | urethral disorder | University of Alabama at Birmingham | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 91
| Date | Issuer | Release |
|---|---|---|
| 2026-04-15 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication of Steady-State Pharmacokinetics of TONMYA® After 20 Days of Daily Dosing in the Peer-Reviewed Journal, Clinical Pharmacology in Drug Development tonixpharma.com ↗
The dynamic changes in cyclobenzaprine concentrations from sublingual tablet dosing over 24 hours at Day 20 are believed to provide pharmacodynamic effects on the brain owing to rapid absorption and distribution. |
| 2026-03-10 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Post Hoc Analyses of Phase 3 Data on TONMYA™ at the 8th International Congress on Controversies in Fibromyalgia tonixpharma.com ↗
In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with durable pain reduction and significant improvements in all key secondary endpoints as compared to placebo |
| 2026-03-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data on TONMYA™ in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting tonixpharma.com ↗
Treatment with TONMYA provided statistically significant pain reduction in two Phase 3 trials and was generally well tolerated |
| 2026-03-05 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Studies of TONMYA™ and Prototype Formulations in the Journal Clinical Pharmacology in Drug Development tonixpharma.com ↗
The sublingual TONMYA tablet containing a basifying agent achieved the design objectives of rapid transmucosal absorption and bypassing first-pass liver metabolism |
| 2026-01-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Phase 3 RESILIENT Data on TONMYA™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2026 Non-Opioid Pain Therapeutics Summit tonixpharma.com ↗
TONMYA demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study |
| 2025-11-24 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive disorder (MDD) in adults. |
| 2025-10-27 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence tonixpharma.com ↗
Tonmya demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study |
| 2025-09-08 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025 tonixpharma.com ↗
Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo |
| 2025-08-15 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia tonixpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. |
| 2025-07-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine tonixpharma.com ↗
The previously disclosed and now published RESILIENT data show that once-nightly TNX-102 SL achieved statistically significant improvement in the primary endpoint of reducing fibromyalgia pain versus placebo, and was generally well tolerated |
| 2025-06-16 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2025 tonixpharma.com ↗
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized placebo-controlled Phase 3 studies |
| 2025-04-07 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting tonixpharma.com ↗
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two pivotal double-blind randomized Phase 3 studies |
| 2025-03-24 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for TNX-102 SL for the Management of Fibromyalgia tonixpharma.com ↗ |
| 2025-03-04 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at 7th International Congress on Controversies in Fibromyalgia tonixpharma.com ↗
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized Phase 3 studies |
| 2024-12-23 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia tonixpharma.com ↗
Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025 |
| 2024-12-17 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia tonixpharma.com ↗
The FDA has accepted the NDA filing for TNX-102 SL for fibromyalgia. |
| 2024-11-18 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting tonixpharma.com ↗
In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. |
| 2024-10-16 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA) tonixpharma.com ↗ |
| 2024-09-23 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Data Presentations on TNX-102 SL for Fibromyalgia at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024) tonixpharma.com ↗
Results from the confirmatory Phase 3 RESILIENT study of TNX-102 SL demonstrated statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality |
| 2024-08-28 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the 2024 Military Health System Research Symposium (MHSRS) tonixpharma.com ↗
In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. |
| 2024-08-21 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Oral Presentation and Three Poster Presentations at the 2024 Military Health System Research Symposium (MHSRS) tonixpharma.com ↗
Oral presentation highlights TNX-102 SL (sublingual cyclobenzaprine HCl) treatment in Phase 3 RESILIENT study demonstrating statistically significant improvement in fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality |
| 2024-08-12 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia, the Prototypic Nociplastic Pain Syndrome, at the IASP 2024 World Congress on Pain tonixpharma.com ↗
TNX-102 SL met the pre-specified primary endpoint in the Phase 3 RESILIENT study, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. |
| 2024-07-25 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. |
| 2024-06-17 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Poster of Tonmya™ for the Management of Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2024 tonixpharma.com ↗
Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated by significant improvement on the primary pain endpoint and on all six key secondary endpoints |
| 2024-06-03 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented New Data on Tonmya™ Suggesting Activity for Improvement in Fibromyalgia-Associated Depression Severity in an Oral Presentation at ASCP Annual Meeting tonixpharma.com ↗
Tonmya treatment was associated with improvement in depressive symptoms as measured by the Beck Depression Inventory-II |
| 2024-05-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Two Poster Presentations of TNX-102 SL (Sublingual Cyclobenzaprine HCl) at the ASCP Annual Meeting tonixpharma.com ↗
In the Phase 2 PREVAIL trial in fibromyalgia-type Long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep and cognitive function |
| 2024-03-11 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia tonixpharma.com ↗
Cognitive dysfunction, or “brain fog,” nominally improved on FIQ-R memory item (p=0.001) where the patients rated their level of memory problems |
| 2024-03-07 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep Quality in Military-Related PTSD at Four Weeks of Therapy tonixpharma.com ↗
Nominal improvement in PTSD severity and measures of sleep quality at Week 4 in the HONOR study support development of bedtime TNX-102 SL therapy in the immediate aftermath of trauma |
| 2024-02-27 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced positive results from its clinical pharmacokinetic (PK) bridging study of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in healthy adult male and female ethnic Japanese and Chinese volunteers. |
| 2024-02-14 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyalgia Trial for Tonmya™, Plans to File NDA for FDA Approval in Second Half of 2024 tonixpharma.com ↗
As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo ( p =0.00005) in participants with fibromyalgia. |
| 2024-02-12 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD tonixpharma.com ↗
today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL |
| 2024-01-29 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, Tonmya™, for the Company's drug product candidate TNX-102 SL for the management of fibromyalgia. |
| 2024-01-25 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces KOL Webinar to Discuss Positive Phase 3 Fibromyalgia Data, Sponsored by A.G.P. tonixpharma.com ↗ |
| 2024-01-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia tonixpharma.com ↗
Results demonstrated a favorable tolerability and side effect profile, including improvement in female sexual function and no increases in weight or blood pressure – three treatment-limiting side effects often observed with currently approved medicines for fibromyalgia |
| 2023-12-20 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia tonixpharma.com ↗
Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. |
| 2023-09-05 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Topline Results from Phase 2 PREVAIL Proof-of-Concept Study of TNX-102 SL for the Management of Fibromyalgia-Type Long COVID tonixpharma.com ↗
TNX-102 SL treatment showed a robust effect size (ES) in improving fatigue and showed consistent activity trending to improvements across the secondary endpoints of sleep quality, cognitive function, disability and patient global impression of change (PGIC). |
| 2023-06-15 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication of Results from Phase 3 RELIEF Trial of TNX-102 SL for the Management of Fibromyalgia tonixpharma.com ↗
The paper, titled, “ Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo Controlled RELIEF Trial,” includes data demonstrating that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. |
| 2023-03-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Positive Efficacy and Safety Data from Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia at the 5th International Congress on Controversies in Fibromyalgia tonixpharma.com ↗
Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). |
| 2022-04-06 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC) tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL 1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. |
| 2022-03-21 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Phase 3 RALLY Study Results for TNX-102 SL 5.6 mg for the Management of Fibromyalgia tonixpharma.com ↗
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 1 did not achieve statistical significance on the primary endpoint of reducing fibromyalgia (FM) daily pain at Week 14 compared to placebo ( p =0.115) in the Phase 3 RALLY study. |
| 2021-11-08 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Positive Results from Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia at the American College of Rheumatology Convergence 2021 tonixpharma.com ↗
TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. |
| 2021-07-23 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Outcome of Interim Analysis of Phase 3 RALLY Study of TNX-102 SL for the Management of Fibromyalgia tonixpharma.com ↗
RALLY Study Will Stop Enrolling New Participants Following Recommendation from an Interim Analysis Indicating Inadequate Separation from Placebo at Week-14 in the First 50% of Participants, Based on the Original Targeted Study Size |
| 2021-06-03 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Positive Results from Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia at the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting tonixpharma.com ↗
TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints measuring improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery. |
| 2020-12-21 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Topline Results from Phase 3 RECOVERY Study of TNX-102 SL in PTSD and Outlines Future Development Plans tonixpharma.com ↗
The RECOVERY study did not achieve statistical significance in the prespecified primary efficacy endpoint of change from baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between TNX-102 SL and placebo (p=0.343) (Table 1). |
| 2020-12-07 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia tonixpharma.com ↗ |
| 2020-08-06 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces Clearance of IND for TNX-102 SL for Treatment of Alcohol Use Disorder tonixpharma.com ↗
today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD). |
| 2020-02-05 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 RECOVERY Study of Tonmya® (TNX-102 SL) in PTSD tonixpharma.com ↗
RECOVERY Study has Stopped Enrollment Due to Inadequate Separation from Placebo at Week-12 Based on Interim Analysis Results of the First 50% of Enrolled Participants |
| 2020-01-24 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Successful Completion of a Fed-Fasting and Dose Proportionality Study of TNX-102 SL tonixpharma.com ↗
The study also showed the rate and extent of absorption of cyclobenzaprine increase in a dose proportional manner from 2.8 mg to 5.6 mg for TNX-102 SL. |
| 2019-05-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Results from Pharmacokinetic Analyses of TNX-102 SL in a Poster Presentation at the American Society of Clinical Psychopharmacology tonixpharma.com ↗
The poster presentation reports PK results of TNX-102 SL, a sublingual form of cyclobenzaprine (CBP), studied in a comparative PK, open-label, randomized, parallel, two-arm, multiple-dose bridging study, with the reference listed drug AMRIX® (cyclobenzaprine HCl extended release capsules). |
| 2019-04-22 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces that Breakthrough Therapy Designation Remains in Effect for Tonmya® for the Treatment of Posttraumatic Stress Disorder tonixpharma.com ↗
Tonix also announced that FDA has reversed itself and granted the Company a meeting in June to present additional data to support continuing Breakthrough Therapy designation. |
| 2019-03-01 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Provides Update on Tonmya® for the Treatment of Posttraumatic Stress Disorder tonixpharma.com ↗
The rescission of Breakthrough Therapy designation of Tonmya for PTSD does not alter our NDA plan and will have minimum impact on our future interactions with the FDA. |
| 2018-11-06 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Results and Retrospective Analyses of Phase 3 P301 “HONOR” Study in Poster Presentation at CNS Summit 2018 tonixpharma.com ↗
The poster presentation reports that a retrospective analysis revealed a treatment effect in participants who experienced trauma less than or equal to nine years prior to screening (approximately 50% of the modified intent-to-treat population). |
| 2018-08-21 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Results and Retrospective Analyses of Two Double-Blind, Randomized Placebo-Controlled 12-Week Studies of Tonmya® in Military-Related PTSD at the 2018 Military Health System Research Symposium tonixpharma.com ↗
Today’s poster presentation reports that a retrospective analysis revealed a treatment effect in participants who experienced trauma less than or equal to nine years prior to screening (approximately 50% of the mITT population). |
| 2018-07-27 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 HONOR Study of Tonmya® in Military-Related PTSD tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), today announced that it will stop the Phase 3 HONOR study of Tonmya*(cyclobenzaprine HCl sublingual tablets) in military-related posttraumatic stress disorder (PTSD) due to inadequate separation from placebo on the primary endpoint at week 12. |
| 2018-07-16 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for TNX-102 SL for Treatment of Agitation in Alzheimer’s Disease tonixpharma.com ↗
NEW YORK, July 16, 2018 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational new drug, TNX-102 SL, for the treatment of agitation in Alzheimer’s disease. |
| 2018-05-31 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented New Data Related to Suicidal Ideation and Behaviors in Military-Related PTSD from the Phase 2 AtEase Study at the American Society of Clinical Psychopharmacology tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), presented data from the Phase 2 AtEase study of Tonmya®* (cyclobenzaprine HCl sublingual tablets) for the treatment posttraumatic stress disorder (PTSD). |
| 2018-05-24 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Preliminary Results from a Phase 1 Pivotal Multiple-Dose Bridging Pharmacokinetic (PK) Study of Tonmya® or TNX-102 SL tonixpharma.com ↗
In addition, the systemic exposure of cyclobenzaprine and the major active metabolite norcyclobenzaprine from TNX-102 SL is less than the RLD AMRIX at the steady-state. |
| 2017-08-29 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Additional Phase 2 Clinical Results in Military-Related PTSD and Design of Ongoing Phase 3 Trial at the 2017 Military Health System Research Symposium tonixpharma.com ↗
Phase 2 Study of U.S. FDA-Designated Breakthrough Therapy Tonmya® (Cyclobenzaprine HCI Sublingual Tablets) in PTSD Indicates Early Sleep Quality Improvements Correlate with Later Response to Treatment |
| 2017-07-06 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya® as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of PTSD tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix) a company that is developing innovative pharmaceutical products to address public health challenges today reported that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed trade name Tonmya ( ton-MY-ah ) for TNX-102 SL* (cyclobenzaprine HCl sublingual tablets) for the management of posttraumatic stress disorder (PTSD). |
| 2017-05-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Retrospective Analyses of Treatment Response and Remission to TNX-102 SL in a Phase 2 Military-Related PTSD Study tonixpharma.com ↗
Baseline PTSD severity threshold was a potential moderator of treatment response. |
| 2017-05-22 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented Analyses of Potential Moderators of Treatment Response to U.S. FDA-Designated Breakthrough Therapy for PTSD, TNX-102 SL, in Phase 2 AtEase Study in Military-Related PTSD tonixpharma.com ↗
In the AtEase CAPS-5 ≥33 subset, the effect size of TNX-102 SL** 5.6 mg is approximately 0.5 on total CAPS-5 and also approximately 0.5 on cluster B (intrusion) and cluster E (arousal and reactivity) scores. |
| 2016-12-19 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals’ PTSD Phase 3-Ready Drug Candidate, TNX-102 SL, Granted Breakthrough Therapy Designation by the FDA tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is developing a next-generation treatment for PTSD, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD). |
| 2016-12-08 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented New Clinical Results from Sub-Group Analysis of Phase 2 AtEase Study in Military-Related Posttraumatic Stress Disorder (PTSD) tonixpharma.com ↗
The sub-group analysis confirmed that patients with combat-related PTSD and entry CAPS-5 ≥ 33, treated with TNX-102 SL, 5.6 mg, showed improvement on total CAPS-5 severity, in addition to certain items in CAPS-5 cluster scores, such as reckless and self-destructive behavior. |
| 2016-11-10 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals to Present New Clinical Results from Retrospective Analysis of Phase 2 AtEase Study in Military-Related PTSD tonixpharma.com ↗
The analysis revealed that at the 5.6 mg dose, TNX-102 SL had a significant improvement (p=0.012) in reckless or self-destructive behavior |
| 2016-09-06 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Topline Results from Phase 3 AFFIRM Study of TNX-102 SL in Fibromyalgia and Provides Corporate Update tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix) announced preliminary topline results from its Phase 3 clinical study, AFFIRM, designed to evaluate the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, in patients with fibromyalgia. |
| 2016-08-29 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for TNX-102 SL in Post-Traumatic Stress Disorder tonixpharma.com ↗
These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD. |
| 2016-06-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents at EULAR Results of a Retrospective Analysis from the Phase 2b BESTFIT Clinical Study of TNX-102 SL in Fibromyalgia tonixpharma.com ↗ |
| 2016-05-31 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Positive Results from Phase 2 AtEase Study of TNX-102 SL in Post-Traumatic Stress Disorder (PTSD) at the American Society of Clinical Psychopharmacology (ASCP) 2016 Annual Meeting tonixpharma.com ↗ |
| 2016-05-19 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Positive Topline Results from Phase 2 AtEase Study of TNX-102 SL in Post-Traumatic Stress Disorder (PTSD) tonixpharma.com ↗
The retention rate was higher than typical for a PTSD clinical trial, since 73% completed the study on placebo, 79% on TNX-102 SL 2.8 mg and 84% on TNX-102 SL 5.6 mg. |
| 2016-03-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Pharmacokinetic Data on TNX-102 SL as a Potential Treatment for the Management of Fibromyalgia and Treatment of Post-Traumatic Stress Disorder at the ASCPT 2016 Annual Meeting tonixpharma.com ↗
TNX-102 SL pharmacokinetic data demonstrated increased plasma levels of 338% during the first hour and 83% during the first two hours after administration compared with immediate-release cyclobenzaprine oral tablet |
| 2015-11-10 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Additional Data on Tonmya(TM) Demonstrating Improvements in Sleep, Pain, and Other Outcomes in Fibromyalgia at 2015 ACR/ARHP Annual Meeting tonixpharma.com ↗
We also observed that the group treated with Tonmya was approximately twice as likely as placebo-treated patients to be in the top third of reported sleep quality improvement. |
| 2015-06-17 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for Cyclobenzaprine HCl Sublingual Tablets, 2.8 mg tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) ("Tonix") today reported that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed trade name Tonmya™ ( ton-MY-ah ) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, for the management of fibromyalgia. |
| 2015-06-11 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Additional Data From Phase 2b BESTFIT Clinical Study at EULAR tonixpharma.com ↗
today presented additional data from its Phase 2b BESTFIT clinical study further supporting TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a promising treatment candidate for patients with fibromyalgia. |
| 2015-05-15 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Data at the Annual Meeting of the Society for Biological Psychiatry tonixpharma.com ↗
In the current studies, neither CBP nor its major metabolite, norcyclobenzaprine, or nCBP, demonstrated any agonist effects on the serotonin 2C receptor. |
| 2015-01-06 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Provides Clinical and Regulatory Update on its Continued Development of TNX-102 SL in Fibromyalgia tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) has received written guidance from the U.S. Food and Drug Administration (FDA) on its Phase 3 clinical study design for TNX-102 SL in fibromyalgia. |
| 2014-09-29 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Top Line Results From Phase 2b BESTFIT Trial of TNX-102 SL in Patients With Fibromyalgia tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) today announced top line results of the Phase 2b BESTFIT (BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy) study of TNX-102 SL as a chronic bedtime treatment for fibromyalgia. |
| 2014-06-10 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Receives IND Clearance From U.S. Food and Drug Administration for TNX-102 SL in Post-Traumatic Stress Disorder tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl, for the treatment of post-traumatic stress disorder (PTSD). |
| 2013-08-19 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Nonclinical Results at the Ninth World Congress on Myofascial Pain Syndrome and Fibromyalgia Syndrome tonixpharma.com ↗
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) , a specialty pharmaceutical company developing novel treatments for challenging disorders of the central nervous system (CNS), including fibromyalgia and post-traumatic stress disorder (PTSD), presented results from nonclinical studies of cyclobenzaprine (CBP), the active ingredient of Tonix's lead candidate, TNX-102 sublingual tablet (TNX-102 SL), at the International Pain Society's Ninth World Congress on Myofascial Pain Syndrome and Fibromyalgia Syndrome in Seattle, Washington. |
| 2013-03-11 | Tonix Pharmaceuticals, Inc. | Regulatory TONIX Completes Pre-Phase 3 Meeting With U.S. Food and Drug Administration for TNX-102 SL in Fibromyalgia tonixpharma.com ↗
Official FDA meeting minutes indicate FDA acceptance of the clinical program and provide clear direction to achieve a successful NDA filing of TNX-102 SL in FM. |
| 2012-11-13 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presents Research Findings at the 2012 American College of Rheumatology Annual Scientific Meeting tonixpharma.com ↗
In in vitro receptor studies, both CBP and nCBP were shown to be potent antagonists of certain central nervous system receptors, including the serotonin 5-HT 2A receptor, the histamine H 1 receptor, and the alpha-adrenergic 1 A receptor (Table 1). |
| 2012-10-23 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Confirms Clinical Utility of TNX-102 Sublingual Tablet tonixpharma.com ↗
In comparison to oral administration of the 5 mg CBP tablet, both sublingual doses of TNX-102 SL demonstrated faster systemic absorption. |
| 2012-09-19 | Tonix Pharmaceuticals, Inc. | Results TONIX Pharmaceuticals Announces Poster Presentation at the 2012 American College of Rheumatology Annual Scientific Meeting tonixpharma.com ↗
The abstract presents data showing blood levels of a metabolite, norcyclobenzaprine (nCBP), were unexpectedly high and persistent in healthy volunteers who ingested a 5 mg tablet of cyclobenzaprine (CBP). |
| 2012-08-14 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports That Sublingual Formulation of Fibromyalgia Drug Reduces Production of a Psychoactive Metabolite, Improving Suitability for Long-Term, Chronic Treatment tonixpharma.com ↗
The study showed that levels of the norcyclobenzaprine metabolite can be reduced by using a sublingual formulation compared to oral cyclobenzaprine tablets. |
| 2012-07-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Completion of Clinical Trial of Sublingual TNX-102 tonixpharma.com ↗
Results Support Development as a Bedtime Therapy for Fibromyalgia |
| 2012-07-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Positive Preclinical Data on Sublingual TNX-102 tonixpharma.com ↗ |
| 2012-06-27 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Receives Health Canada Clearance to Study a Novel Treatment for Fibromyalgia tonixpharma.com ↗
Health Canada has issued a No Objection Letter to TONIX’s Clinical Trial Application. |
| 2012-04-05 | Tonix Pharmaceuticals, Inc. | Results TONIX Pharmaceuticals Completes Pharmacokinetic Study on New Formulation of TNX-102 for Fibromyalgia tonixpharma.com ↗
The study results support further development of TNX-102 as a product that can potentially deliver benefits similar to those observed in FM patients treated with very low dose cyclobenzaprine in the Company’s dose-escalating Phase 2a study. |
| 2011-11-18 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Receives FDA Clearance to Initiate a Pharmacokinetic Study of TNX-102 For Fibromyalgia tonixpharma.com ↗
TONIX also received clearance from Health Canada, which issued a No Objection Letter to the Company’s Clinical Trial Application. |
| 2011-09-07 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals' Bedtime Very Low Dose Cyclobenzaprine Study Featured in Journal of Rheumatology tonixpharma.com ↗
This study showed bedtime treatment with VLD CBP improved core FM symptoms of pain, tenderness, fatigue, and depressed mood. |
| 2011-06-16 | Tonix Pharmaceuticals, Inc. | Results TONIX Pharmaceuticals Presents Findings on the Effects of Bedtime Very Low Dose (VLD) Cyclobenzaprine (CBP) on Symptoms and Sleep Physiology in Patients with Fibromyalgia Syndrome tonixpharma.com ↗
In the new findings, VLD CBP treatment improved sleep efficiency and increased the number of nights with reduced rates of EEG Cyclic Alternating Pattern (CAP) sleep types CAPA2 + CAPA3, which are associated with sleep instability and previously were shown to be elevated in FM patients. |
| 2010-11-09 | Tonix Pharmaceuticals, Inc. | Results TONIX Pharmaceuticals Reports Analysis of Phase 2a Study of Very Low Dosage Cyclobenzaprine in Fibromyalgia Syndrome (FMS) tonixpharma.com ↗
According to the analysis, VLD CBP treatment was associated with reductions in an objective measure of non-REM sleep instability, referred to as Cyclic Alternating Patterns (CAP) A2 & A3; these reductions were statistically significantly correlated with diminished pre-sleep/p.m. fatigue in FMS. |
All press releases naming this drug 149 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 149 releases opens the full record — a long page | ||
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cyclobenzaprine | “The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the...” NCT02829814 ↗39“TNX-102 SL is a bedtime sublingual formulation of cyclobenzaprine with potent binding and antagonist activity at 5-HT2A, α1-adrenergic, H1 histaminergic, and M1 muscarinic...” PMID 38350291 ↗ Feb 2024 “This 12-week randomized multicenter trial evaluated efficacy and safety of TNX-102 SL, a bedtime sublingual formulation of cyclobenzaprine, in patients with military-related...” PMID 33979763 ↗ Apr 2021 “This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg...” NCT05372887 ↗ “OBJECTIVE: To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing pain in patients with fibromyalgia (FM).” PMID 37165930 ↗ Jul 2023 “TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess)” NCT01689259 ↗ “sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess)” NCT01634412 ↗ “Cyclobenzaprine HCl sublingual tablets. The tablets are yellow, round, and biconvex with a "T" debossed on one face” NCT07464535 ↗ “Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.” NCT01421433 ↗ “2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days” NCT03443960 ↗ “a study drug called TNX-102 SL [cyclobenzaprine hydrochloride (HCl) sublingual (SL) tablets]” NCT07413367 ↗ |
| Known as | AMRIX | “AMRIX® (cyclobenzaprine HCl ER Capsules) 30 mg” NCT03443960 ↗ |
| Known as | Cyclobenzaprine HCl | “Cyclobenzaprine HCl sublingual tablets. The tablets are yellow, round, and biconvex with a "T" debossed on one face” NCT07464535 ↗4“Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories” NCT00913419 ↗ “cyclobenzaprine HCl sublingual tablets” NCT03508700 ↗ |
| Known as | cyclobenzaprine hydrochloride | “a study drug called TNX-102 SL [cyclobenzaprine hydrochloride (HCl) sublingual (SL) tablets]” NCT07413367 ↗5“one 5 days cycle of cyclobenzaprine hydrochloride (10 mg a day)” NCT03119324 ↗ “cyclobenzaprine hydrochloride 15 mg capsule (XL - Mitrul®)” NCT05683574 ↗ “Drug: Cyclobenzaprine Hydrochloride 10 MG” NCT04407377 ↗ |
| Known as | cyclobenzaprine hydrochloride is Amrix 15mg/daily | “cyclobenzaprine hydrochloride is Amrix 15mg/daily” NCT01151787 ↗ |
| Known as | Flexeril | “Cyclobenzaprine, aka Flexeril®, is NOT an experimental drug and is already approved by the Food and Drug Administration (FDA) for acute, painful muscle spasms.” NCT07664956 ↗2“Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management of acute musculoskeletal injuries” NCT01081990 ↗ |
| Known as | Miosan | “cyclobenzaprine - Miosan®” NCT01587508 ↗ |
| Known as | TNX-102 | “TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess)” NCT01689259 ↗ |
| Known as | TNX-102 SL | “The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the...” NCT02829814 ↗7“TNX-102 SL is a bedtime sublingual formulation of cyclobenzaprine with potent binding and antagonist activity at 5-HT2A, α1-adrenergic, H1 histaminergic, and M1 muscarinic...” PMID 38350291 ↗ Feb 2024 “This 12-week randomized multicenter trial evaluated efficacy and safety of TNX-102 SL, a bedtime sublingual formulation of cyclobenzaprine, in patients with military-related...” PMID 33979763 ↗ Apr 2021 “This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg...” NCT05372887 ↗ “OBJECTIVE: To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing pain in patients with fibromyalgia (FM).” PMID 37165930 ↗ Jul 2023 “TNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.” NCT06636786 ↗ “2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days” NCT03443960 ↗ “TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine” NCT03841773 ↗ |
| Known as | XL - Mitrul | “cyclobenzaprine hydrochloride 15 mg capsule (XL - Mitrul®)” NCT05683574 ↗ |
| Action | Inhibit | “potent binding and antagonist activity at 5-HT2A, α1-adrenergic, H1 histaminergic, and M1 muscarinic receptors” PMID 38350291 ↗ Feb 2024 |
| Route | Oral | “Patients receive cyclobenzaprine HCl 5 mg administered orally three times a day for one week” NCT00246389 ↗ |