Drugs / Meloxicam
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | moderate-to-severe acute pain | 2026-05-18 | “FDA has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain” viatris.com ↗ |
| Withdrawn | EU (EMA) | Zynrelef | — | 2023-10-05 | europa.eu ↗ |
| Filed | US (FDA) | ZYNRELEF | postsurgical analgesia | 2022-12-29 | “today announced the submission of a supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution” herontx.com ↗ |
| Filed | US (FDA) | ZYNRELEF | — | 2021-10-04 | “today announced submission of a supplemental New Drug Application (NDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution for an expanded indication.” herontx.com ↗ |
| Approved | EU (EMA) | Zynrelef | — | 2020-09-24 | europa.eu ↗ |
| Rejected (CRL) | US (FDA) | — | — | 2019-04-25 | “second complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for IV Meloxicam.” alkermes.com ↗ |
| Rejected (CRL) | US (FDA) | — | — | 2018-07-26 | “receipt of a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for IV Meloxicam.” alkermes.com ↗ |
| Label expansions (2) | US (FDA) | MOBIC | — | 2004-07-16 – 2005-08-11 | fda.gov ↗ |
| Approved | US (FDA) | MOBIC | — | 2000-04-13 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06349772 | Nov 2024 → Nov 2027 expected | — | Texas Tech University Health Sciences Center | Recruiting | No outcome recorded |
| Phase 119 trials · 1 met primary | ||||||
| Phase 1 | NCT05181124 | Mar 2021 | active peptic ulcer disease | Onconic Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04490434 | Jun → Aug 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04322175 | Dec 2019 → Jun 2020 | — | Beijing Tongren Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03684265 | Oct 2018 | — | Boehringer Ingelheim | Completed | Mixed |
| Phase 1 | NCT03354117 | Mar 2018 → May 2019 | — | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT05125588 | Jan → Feb 2014 | — | Joint Stock Company "Farmak" | Completed | No outcome recorded |
| Phase 1 | NCT01839643 | Jan → May 2013 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00731302 | Apr 2005 → Apr 2017 | systemic lupus erythematosus | Vanderbilt University | Completed | No outcome recorded |
| Phase 1 | NCT00649675 | Aug → Sep 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00649077 | Aug → Sep 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00840879 | Feb 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00840476 | Feb 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT02187562 | Jul → Aug 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02181309 | Jan → Apr 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02181322 | Jun → Sep 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183142 | Mar → Apr 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02276352 | Jun → Aug 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183103 | Apr → May 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183077 | Sep → Nov 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06403046 | Jun 2024 → May 2025 | temporomandibular joint disorder | Beni-Suef University | Completed | No outcome recorded |
| Phase 1/2 | NCT04398329 | May 2020 → Jul 2021 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 216 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT05950152 | Jul → Dec 2023 | neuropathy, painful | Beijing Tide Pharmaceutical Co., Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT05695352 | Jun 2022 → Nov 2024 | — | InnovaGyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04911062 | Apr → Jul 2022 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT04115098 | Jun 2020 → Aug 2023 | spondyloarthropathy | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03695367 | Oct → Nov 2018 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02540265 | Aug → Nov 2015 | — | Baudax Bio | Completed | No outcome recorded |
| Phase 2 | NCT02405793 | May → Jul 2015 | osteoarthritis | Iroko Pharmaceuticals, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02078102 | Mar 2014 → Nov 2018 | non-Hodgkin lymphoma, plasma cell myeloma | Sherif S. Farag | Completed | No outcome recorded |
| Phase 2 | NCT02003625 | Oct 2013 → Feb 2019 | Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01799213 | Sep 2013 → Oct 2018 | osteoarthritis, knee | VA Office of Research and Development | Completed | Missed primary |
| Phase 2 | NCT01346137 | Jan → Apr 2011 | — | Instituto Chileno de Medicina Reproductiva | Unknown | No outcome recorded |
| Phase 2 | NCT01084161 | Mar 2010 → Jan 2011 | — | Alkermes, Inc. | Completed | Met primary |
| Phase 2 | NCT00945763 | Jul → Nov 2009 | — | Alkermes, Inc. | Completed | Met primary |
| Phase 2 | NCT02183038 | Jul 1998 → Feb 1999 | pharyngitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02183051 | Apr → Oct 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02183025 | Jan 1998 → Apr 1999 | primary dysmenorrhea | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02255045 | Jun 2014 → Feb 2016 | primary dysmenorrhea | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 332 trials · 7 met primary · 1 missed | ||||||
| Phase 3 | NCT06904248 | Jan → Nov 2024 | — | Yangtze River Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT07463404 | Dec 2023 → Jun 2025 | temporomandibular joint disorder | Suez Canal University | Completed | No outcome recorded |
| Phase 3 | NCT06379165 | May → Jul 2023 | — | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05751421 | Feb 2023 → Feb 2024 | neuropathy, painful | Rothman Institute Orthopaedics | Unknown | No outcome recorded |
| Phase 3 | NCT05702827 | Jan 2023 → Mar 2024 | female stress incontinence, vulvar disease | TriHealth Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05550207 | Aug 2022 → Nov 2024 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT05291598 | May 2022 → May 2023 | — | University of Miami | Completed | No outcome recorded |
| Phase 3 | NCT04725357 | Jan 2021 → Jan 2022 | arthropathy | Rothman Institute Orthopaedics | Unknown | No outcome recorded |
| Phase 3 | NCT04163185 | Oct 2019 → Mar 2020 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04068051 | Jul 2019 → Sep 2020 | migraine disorder | Axsome Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03936192 | Jan 2019 → Feb 2021 | osteoarthritis, knee | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT03586934 | Jun 2018 → Jun 2019 | substance-related disorder | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03434275 | Feb 2018 → May 2019 | — | Baudax Bio | Completed | Met primary |
| Phase 3 | NCT03323385 | Oct 2017 → Sep 2018 | neuropathy, painful | Baudax Bio | Completed | No outcome recorded |
| Phase 3 | NCT03295721 | Oct 2017 → Jan 2018 | — | Heron Therapeutics | Completed | Met primary |
| Phase 3 | NCT02720692 | Mar 2016 → Mar 2017 | — | Baudax Bio | Completed | No outcome recorded |
| Phase 3 | NCT02675907 | Jan → Jul 2016 | — | Baudax Bio | Completed | Met primary |
| Phase 3 | NCT02678286 | Jan → Oct 2016 | neuropathy, painful | Baudax Bio | Completed | Met primary |
| Phase 3 | NCT02060006 | Apr 2014 → Apr 2015 | tuberculosis | University of Stellenbosch | Unknown | No outcome recorded |
| Phase 3 | NCT01979510 | Nov 2013 → May 2014 | — | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT01801735 | Mar 2013 → Jun 2014 | osteoarthritis | Iroko Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01787188 | Feb → Oct 2013 | osteoarthritis | Iroko Pharmaceuticals, LLC | Completed | Met primary |
| Phase 3 | NCT02706054 | May 2012 → Jul 2014 | — | Rizzoli Orthopaedic Institute | Completed | No outcome recorded |
| Phase 3 | NCT01436032 | Oct 2011 → Mar 2012 | — | Alkermes, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00239382 | Jul → Dec 2004 | rheumatoid arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00239395 | Jul → Dec 2004 | osteoarthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00152919 | Feb 2004 → May 2009 | prostate neoplasm | University Health Network, Toronto | Completed | Missed primary |
| Phase 3 | NCT00042068 | Jun 2002 → Jul 2003 | rheumatoid arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02183168 | Jul 2001 → May 2002 | ankylosing spondylitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00034853 | Dec 2000 → Jun 2003 | juvenile idiopathic arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00279747 | Sep 2000 → Jan 2003 | juvenile idiopathic arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02183064 | Oct 1998 → Nov 2000 | osteoarthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT07216586 | Jan 2027 → Jan 2028 expected | osteoarthritis, knee | University of Miami | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07430085 | Jul 2026 → Jan 2028 expected | osteoarthritis, knee | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07200544 | Oct 2025 → Jun 2026 overdue | skin cancer | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 4 | NCT07076069 | Jul 2025 → Jun 2028 expected | rotator cuff syndrome | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05863221 | May 2023 → Oct 2024 | — | Dr. Yannis Raftopoulos | Unknown | No outcome recorded |
| Phase 4 | NCT05644496 | Mar 2023 → Dec 2025 | osteoarthritis, knee | Baptist Health South Florida | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05315479 | Feb → Jul 2022 | — | Baudax Bio | Terminated | No outcome recorded |
| Phase 4 | NCT02298218 | Sep 2009 → Jun 2011 | biliary atresia | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00635349 | May 2007 → Apr 2009 | osteoarthritis | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase 4 | NCT02229747 | Aug 2001 → Feb 2002 | pharyngitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02183155 | May → Sep 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02183129 | Apr → Nov 1999 | osteoarthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02183116 | Oct 1998 → Feb 1999 | osteoarthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase not applicable3 trials · 1 met primary · 1 missed | ||||||
| — | NCT04176783 | Mar 2018 → Jul 2021 | — | OrthoCarolina Research Institute, Inc. | Completed | No outcome recorded |
| — | NCT04003350 | Dec 2017 → Nov 2018 | osteoarthritis, knee | Rothman Institute Orthopaedics | Completed | Missed primary |
| — | NCT01430559 | Oct 2011 → Mar 2013 | osteoarthritis, knee | Pfizer | Completed | Met primary |
| Comparator or background therapy26 trials | ||||||
| Phase 1 | NCT06902090 Comparator | Jul 2023 | — | Yangtze River Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02183090 Comparator | Nov → Dec 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT06306131 Comparator | Dec 2023 → Nov 2025 | — | InnovaGyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02456363 Background | Nov 2009 → Oct 2019 | ankylosing spondylitis | Chung Shan Medical University | Unknown | No outcome recorded |
| Phase 2/3 | NCT04480359 Comparator | Oct 2017 → Aug 2020 | ankylosing spondylitis | Shanghai University of Traditional Chinese Medicine | Unknown | 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 | NCT07549386 Comparator | May 2024 → Mar 2025 | osteoarthritis | Laboratorios Liomont | Completed | No outcome recorded |
| Phase 3 | NCT03907176 Background | Apr 2019 → Oct 2021 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03896009 Comparator | Mar → Dec 2019 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT03146000 Comparator | May 2017 → Aug 2018 | puerperal disorder | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT02448199 Comparator | Jul 2015 → Jun 2016 | osteoarthritis | Zodiac Produtos Farmaceuticos S.A. | Unknown | No outcome recorded |
| Phase 3 | NCT01789216 Comparator | Jul 2013 → Dec 2018 | — | Major Extremity Trauma Research Consortium | Completed | No outcome recorded |
| Phase 3 | NCT01587508 Comparator | May 2013 | — | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01147289 Comparator | Feb → Nov 2011 | sciatica | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 4 | NCT07158476 Comparator | Oct 2025 → Sep 2030 expected | — | St. Louis University | Recruiting | No outcome recorded |
| Phase 4 | NCT06704113 Comparator | Dec 2024 → Jan 2025 overdue | dental pulp disorder, perceptual disorders | Universidad Austral de Chile | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05974501 Background | Sep 2023 → Jan 2024 | osteoarthritis, knee | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT04766996 Background | May → Dec 2021 | substance-related disorder | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT03473665 Comparator | Mar 2018 → Aug 2019 | ankylosing spondylitis | Columbia University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT07493226 Comparator | Apr 2026 → Feb 2027 expected | frozen shoulder, neuropathy, painful | Konya Beyhekim Training and Research Hospital | Recruiting | No outcome recorded |
| — | NCT07743684 Comparator | Jan 2026 → Apr 2027 expected | temporomandibular joint disorder | Hussein Mohammed Ridha | Active not recruiting | No outcome recorded |
| — | NCT07462988 Comparator | Jan → Jun 2025 | — | Istanbul Medeniyet University | Completed | No outcome recorded |
| — | NCT05672784 Comparator | Nov 2022 → Dec 2024 overdue | — | Zagazig University | Recruiting | No outcome recorded |
| — | NCT05097768 Comparator | Aug 2021 → Jan 2022 | pulpitis | Alfarabi Colleges | Completed | No outcome recorded |
| — | NCT04538391 Comparator | Mar 2019 → Mar 2020 | — | Menoufia University | Completed | No outcome recorded |
| — | NCT01638962 Comparator | Aug 2012 → Aug 2015 | osteoarthritis, knee | University of Southern Denmark | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. |
| 2025-06-23 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - MELOXICAM INJECTION (III) OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
MELOXICAM INJECTION ( Ⅲ) OBTAINS DRUG REGISTRATION APPROVAL |
| 2025-05-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results Viatris Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Novel Fast-Acting Meloxicam (MR-107A-02) for the Treatment of Moderate-to-Severe Acute Pain viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results from its Phase 3 program of the novel fast-acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain. |
| 2025-02-24 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces SYMBRAVO® (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors gcs-web.com ↗
SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint) |
| 2025-01-30 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults gcs-web.com ↗ |
| 2024-09-25 | Heron Therapeutics | Regulatory Heron Therapeutics Announces FDA Approval of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle ("VAN") herontx.com ↗
Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Prior Approval Supplement Application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. |
| 2023-01-05 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - MELOXICAM NANOCRYSTAL INJECTION OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗
has obtained approval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. |
| 2022-12-29 | Heron Therapeutics | Regulatory Heron Therapeutics Announces Filing of an Efficacy Supplement for ZYNRELEF® and Provision in Newly Passed Congressional Bill Anticipated to Provide Separate Reimbursement Outside of the Packaged Surgical Payment for ZYNRELEF herontx.com ↗
Supplemental New Drug Application Submitted Requesting Expansion of Indication to Broadly Cover Soft Tissue and Orthopedic Surgical Procedures |
| 2022-06-14 | Heron Therapeutics | Results Heron Therapeutics Announces Publication Showing ZYNRELEF® as the Foundation of a Perioperative Non-Opioid Multimodal Analgesic Regimen Reduced Severe Pain and Opioid Use in Patients Undergoing Total Knee Arthroplasty herontx.com ↗
The study showed that more than 80% of patients did not experience severe pain at any individual time point through 72 hours after TKA surgery. |
| 2021-12-09 | Heron Therapeutics | Regulatory Heron Therapeutics Announces FDA Approval of a Significant Indication Expansion for ZYNRELEF® herontx.com ↗
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution to significantly expand the indication. |
| 2021-10-04 | Heron Therapeutics | Regulatory Heron Therapeutics Announces Filing of a Supplemental New Drug Application for Significant Expansion of ZYNRELEF® Indication Statement Based on Successful Outcome of FDA Type C Meeting herontx.com ↗
today announced submission of a supplemental New Drug Application (NDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution for an expanded indication. |
| 2021-07-28 | Heron Therapeutics | Results Heron Therapeutics Announces Publication of Results from HOPE (Helping Opioid Prescription Elimination), Showing ZYNRELEF™ Minimizes the Need for Opioids in a Real-World Setting, With 95% of Patients Experiencing an Opioid-free Recovery herontx.com ↗
The findings from this study demonstrate the ability of ZYNRELEF to serve as the foundation of non-opioid multimodal analgesia. |
| 2021-07-21 | Heron Therapeutics | Results Heron Therapeutics Announces Publication Showing Reduction of Pain and Opioid Use Compared to Bupivacaine in Patients 65 and Older with ZYNRELEF™ herontx.com ↗
The analysis, published in the peer-reviewed journal Pain Management, showed that 58% of bunionectomy and 87% of hernia repair patients aged 65 years and older receiving ZYNRELEF required no opioids to manage their postoperative pain through 72 hours following surgery. |
| 2019-09-05 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Positive AXS-07 Phase 1 Trial Results at the 19th Congress of the International Headache Society gcs-web.com ↗
Results of the Phase 1 trial demonstrated that AXS-07 is rapidly absorbed after oral administration, with the MoSEIC meloxicam component also displaying an extended plasma half-life, suggesting the potential for enhanced and sustained efficacy. |
| 2017-07-25 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-06 (MoSEIC™ Meloxicam and Esomeprazole) Meets Primary Endpoint in Phase 1 Clinical Trial gcs-web.com ↗
The median T max for meloxicam, the trial’s primary endpoint, was 9 times faster for AXS-06 as compared to Mobic® (0.5 hour versus 4.5 hours for AXS-06 and Mobic, respectively, p<0.0001). |
| 2015-09-22 | Heron Therapeutics | Results Heron Therapeutics Reports Positive Top-Line Results from Phase 2 Study of HTX-011 in the Management of Post-Operative Pain herontx.com ↗
The primary and all key secondary endpoints in the study were met with a high degree of statistical significance. |
| 2006-07-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Meloxicam Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application ("ANDA") for Meloxicam Tablets, 7.5 mg and 15 mg. |
All press releases naming this drug 21 releases
Evidence & citations 43 cited values
Every value below carries the sentence it was read from. 116 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | meloxicam | “Specific Aim 3: Estimate the incremental cost effectiveness of each adjunctive analgesic therapy relative to standard of care analgesic therapy in the treatment of severe limb...” NCT01789216 ↗101“The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product,...” NCT05125588 ↗ “The study aims to design a randomized controlled trial that compares the effect of intra-articular injection of the non-selective (NSAID) Tenoxicam versus the selective COX-2...” NCT06403046 ↗ “The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two...” NCT06349772 ↗ “ZYNRELEF® is an extended-release, fixed-ratio combination product that contains bupivacaine (a local anesthetic as the free base) and low-dose meloxicam (an NSAID) incorporated...” NCT05863221 ↗ “Acetaminophen 975mg every 4 hours, Meloxicam 7.5mg once per day, Pregabalin 50mg twice per day, Magnesium 400mg once per day, along with rescue Oxycodone 5mg every 4 hours, as needed” NCT07076069 ↗ “Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers” NCT02276352 ↗ “Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.” NCT03354117 ↗ “A single 14 mL dose of HTX-011 containing 400 mg bupivacaine and 12 mg meloxicam will be applied intraoperatively to the surgical site.” NCT07216586 ↗ “Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of meloxicam or lornoxicam” NCT07493226 ↗ “Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis” NCT07463404 ↗ |
| Known as | Acticam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | ANJESO | “Meloxicam Nanocrystal Injection (ANJESO®)” NCT06902090 ↗ |
| Known as | Anticox | “meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals)” NCT04538391 ↗ |
| Known as | Contacera | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Coxicam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Drug: Mobic | “Drug: Mobic” NCT02456363 ↗ |
| Known as | Emdocam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Flexicam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Inflacam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Loxicom | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Loxitab | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Melfax | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Melosus | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Melovem | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Meloxicam component of zeleris | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Meloxicam component of zynrelef | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | MELOXICAM SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Meloxicam/Mobic (NDC 68382-000-01; manufacturer: Zydus; encapsulated in size AA | “Meloxicam/Mobic (NDC 68382-000-01; manufacturer: Zydus; encapsulated in size AA” NCT01789216 ↗ |
| Known as | Meloxidolor | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Meloxidyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Meloxivet | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Meloxoral | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Metacam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Mobic | “The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15...” NCT00649077 ↗3“Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets” NCT00649675 ↗ “Drug: Mobic” NCT02456363 ↗ |
| Known as | Mobitil | “Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis” NCT07463404 ↗ |
| Known as | Movalis | “The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product,...” NCT05125588 ↗ |
| Known as | Movatec | “Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose.” NCT01147289 ↗1“meloxicam - Movatec®” NCT01587508 ↗ |
| Known as | N1539 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01084161 ↗ |
| Known as | Novaquin | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Novem | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Qmiiz odt | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Recocam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Reumoxicam | “The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product,...” NCT05125588 ↗ |
| Known as | Revitacam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Rheumocam | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | SoluMatrix meloxicam | “SoluMatrix meloxicam has been developed with the goal of enabling effective treatment at low doses.” PMID 26503347 ↗ Dec 2015 |
| Known as | UH-AC 62XX | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Known as | Vivlodex | ChEMBL registry synonym — accepted as the source's own label CHEMBL599 ↗ |
| Action | Inhibit | “a cyclooxygenase-2 (COX-2) inhibitor regimen” PMID 20350785 ↗ Mar 20101“Cyclooxygenase-2 inhibitor” CHEMBL599 ↗ |
| Modality | Small molecule | “Nonsteroidal anti-inflammatory medication” PMID 20350785 ↗ Mar 2010 |
| Route | Oral | “meloxicam oral suspension” NCT00034853 ↗ |
| Target | PTGS2 | “Cyclooxygenase-2 inhibitor” CHEMBL599 ↗ |