Drugs / HTX-011
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | postoperative pain | 2020-11-13 | “today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011” herontx.com ↗ |
| Rejected (CRL) | US (FDA) | — | postoperative pain | 2020-06-26 | “A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020” herontx.com ↗ |
| Rejected (CRL) | US (FDA) | — | postoperative pain | 2019-04-30 | “A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019” herontx.com ↗ |
| Filed | US (FDA) | — | postoperative pain | 2018-10-31 | “today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011.” herontx.com ↗ “Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018” herontx.com ↗ “Heron resubmitted an NDA to the FDA for HTX-011 in September 2019” herontx.com ↗ |
| Filed | EU (EMA) | — | postoperative pain | — | “A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019” herontx.com ↗ |
| Filed | Other | — | postoperative pain | — | “Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada.” herontx.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT03922048 | Jul 2023 → Nov 2025 | — | Heron Therapeutics | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03955211 | Jun 2019 → Dec 2021 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03718039 | Oct 2018 → Jan 2019 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03011333 | Jan 2017 → Feb 2018 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03015532 | Jan 2017 → Apr 2018 | — | Heron Therapeutics | Completed | Met primary |
| Phase 2 | NCT02504580 | Jul 2015 → Mar 2017 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02471898 | Jun → Sep 2015 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT03974932 | Jun 2019 → Dec 2020 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03237481 | Jul → Dec 2017 | — | Heron Therapeutics | Completed | Met primary |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT05188053 | Mar 2022 → Apr 2024 | — | Mayo Clinic | Completed | Missed primary |
| Phase 4 | NCT06109415 | Oct 2021 → Jul 2022 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT06109428 | Oct 2021 → Mar 2022 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT05109312 | Oct 2021 → Jun 2024 | — | Heron Therapeutics | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 2020-11-13 | Heron Therapeutics | Regulatory Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain herontx.com ↗
today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. |
| 2020-09-28 | Heron Therapeutics | Regulatory Heron Therapeutics Receives European Commission Authorization for ZYNRELEF™ (HTX-011) for the Treatment of Postoperative Pain 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 European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. |
| 2020-09-16 | Heron Therapeutics | Results Heron Therapeutics Announces Publication of Results from EPOCH 2 Follow-On Study, a Phase 2b Study of HTX-011 in Patients Undergoing Hernia Repair Surgery herontx.com ↗
In this study, more than 90% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) acetaminophen and ibuprofen, remained opioid-free throughout the 72-hour period following hernia repair surgery. |
| 2020-09-08 | Heron Therapeutics | Regulatory Heron Therapeutics Announces Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain herontx.com ↗
SAN DIEGO, Sept. 8, 2020 /PRNewswire/ -- 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 a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for the Company to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of this year. |
| 2020-07-24 | Heron Therapeutics | Regulatory Heron Therapeutics Receives Positive CHMP Opinion for ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain 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 European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for ZYNRELEF (formerly known as HTX-011), intended for the treatment of postoperative pain. |
| 2019-12-16 | Heron Therapeutics | Results Heron Therapeutics Announces Publication of the Mechanism of Action Data for HTX-011, a Dual-Acting Local Anesthetic Being Developed for Management of Postoperative Pain herontx.com ↗
The synergistic mechanism of action of HTX-011 was demonstrated in preclinical and clinical studies. |
| 2019-12-03 | Heron Therapeutics | Regulatory Health Canada Grants Priority Review Status for Heron Therapeutics' New Drug Submission for HTX-011 for Management of Postoperative Pain herontx.com ↗
Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada. |
| 2019-10-28 | Heron Therapeutics | Regulatory Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain herontx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain. |
| 2018-12-31 | Heron Therapeutics | Regulatory FDA Grants Priority Review Designation for Heron Therapeutics’ NDA for HTX-011, a Non-Opioid for Postoperative Pain Management herontx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for Heron’s investigational agent, HTX-011, and has granted it a Priority Review designation. |
| 2018-10-31 | Heron Therapeutics | Regulatory Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management 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 the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. |
| 2017-10-26 | Heron Therapeutics | Regulatory Heron Therapeutics Granted FDA Fast Track Designation for HTX-011 to Reduce Postoperative Pain and the Need for Opioid Analgesics for 72 Hours herontx.com ↗
Heron Therapeutics, Inc. (Nasdaq: HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel best-in-class treatments to address some of the most important unmet patient needs, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s investigational agent, HTX-011, for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. |
| 2017-08-09 | Heron Therapeutics | Results Heron Therapeutics Announces Initiation of Phase 3 Program for HTX-011 in Postoperative Pain Following Successful End-of-Phase 2 Meeting with FDA herontx.com ↗
The unique synergy of bupivacaine and meloxicam in HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in three diverse surgical models: bunionectomy, hernia repair and abdominoplasty. |
| 2016-09-08 | Heron Therapeutics | Results Heron Therapeutics Announces Presentations of Results from Phase 2 Clinical Trial of HTX-011 in Hernia Repair at PAINWeek® 2016 herontx.com ↗
The pain reduction was long-lasting, with a statistically significant, 25.2% reduction through 48 hours (SPI 0-48; p=0.0250). |
| 2016-08-01 | Heron Therapeutics | Results Heron Therapeutics Reports Positive Top-Line Results from Phase 2 Studies of HTX-011 for Management of Post-Operative Pain herontx.com ↗
Statistically and clinically significant reductions in pain intensity through 96 hours after bunion surgery and through 48 hours after hernia surgery |
| 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. |
All press releases naming this drug 25 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HTX-011 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06109415 ↗ |
| Known as | HTX-011-19 | “HTX-011 is the initial formulation studied (HTX-011-19).” NCT02504580 ↗ |
| Known as | ZYNRELEF | “Aim: HTX-011 (ZYNRELEF™) is an extended-release, dual-acting local anesthetic containing bupivacaine and meloxicam.” PMID 34284613 ↗ Jul 20211“A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.” NCT06109415 ↗ |
| Route | Other | “HTX-011 (bupivacaine/meloxicam) by injection.” NCT02504580 ↗ |