COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors), SCNA modulators(Sodium voltage-gated channel alpha subunits modulators)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Pain, Postoperative

Inactive Indication

AnalgesiaBunion

Originator Organization

Heron Therapeutics, Inc.

Active Organization

Heron Therapeutics, Inc.

Inactive Organization-

License Organization

CrossLink Life Sciences LLC

Heron Therapeutics, Inc.

Drug Highest PhaseApproved

First Approval Date

European Union (24 Sep 2020),

Pain, Postoperative

RegulationFast Track (United States)

Structure/Sequence

Molecular FormulaC18H28N2O

InChIKeyLEBVLXFERQHONN-UHFFFAOYSA-N

CAS Registry38396-39-3

View All Structures (2)

Clinical Trials associated with Bupivacaine/Meloxicam

NCT07216586

/ Not yet recruitingPhase 4IIT

Comparing Opioid Consumption Following Total Knee Arthroplasty With The Perioperative Administration of Zynrelef Versus Adductor Canal Block

To compare postoperative MME consumption 72 hours after TKA in patients receiving intraoperative periarticular HTX-011 (Zynrelef) instillation versus adductor canal block.

Start Date01 Jan 2027

Sponsor / Collaborator

University of Miami

NCT07878507

/ Not yet recruitingPhase 4IIT

Use of Smart Knee Implant to Evaluate Efficacy and Superiority of Liposomal Bupivacaine and Bupivacaine With Meloxicam in Early TKA Recovery

This study looks at how three different numbing injections affect how quickly patients recover after knee replacement surgery (total knee arthroplasty, or TKA). Pain after knee replacement is common and can slow down how soon patients get moving again. Doctors often inject a numbing medication around the knee during surgery to help control this pain, but it is not clear which medication helps patients recover fastest in the first few days after surgery.
The study compares three injections that are all FDA approved and already used as part of routine knee replacement care: Exparel (liposomal bupivacaine), Zynrelef (bupivacaine with meloxicam), and Marcaine (bupivacaine). Exparel and Zynrelef are the two groups being studied, and Marcaine is the comparison (control) group.
Adults who are already planning to have a knee replacement may take part. People who join are placed into one of the three injection groups at random, so each person has a one in three chance of receiving each injection. Patients are not told which injection they received. Everything else about the surgery, anesthesia, and recovery care stays the same as usual.
The main goal is to see which injection helps patients recover best in the first three days after surgery. To measure recovery, the study team collects information on pain, pain-medication use, knee motion, activity level, and function. Patients complete short questionnaires about their activity, pain, and quality of life at their regular visits (before surgery and at 3 days, 1 week, 2 weeks, 6 weeks, 3 months, 1 year, and 2 years). A smart knee implant also records information about knee movement and motion at 3 and 7 days after surgery. About 200 people will take part. The study is considered minimal risk, meaning the risks are similar to those of having a knee replacement outside of the study.

Start Date15 Oct 2026

Sponsor / Collaborator

Zimmer Biomet Holdings, Inc.

[+1]

NCT07430085

/ Not yet recruitingPhase 4IIT

Postoperative Pain Outcomes After Use of Bupivacaine-Meloxicam Extended-Release Solution in Robot Assisted Total Knee Arthroplasty: A Prospective Study

Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.

Start Date31 Jul 2026

Sponsor / Collaborator

Allegheny-Singer Research Institute

100 Clinical Results associated with Bupivacaine/Meloxicam

100 Translational Medicine associated with Bupivacaine/Meloxicam

100 Patents (Medical) associated with Bupivacaine/Meloxicam

Literatures (Medical) associated with Bupivacaine/Meloxicam

01 Sep 2026·JOURNAL OF CONTROLLED RELEASE

Triple-layered core-shell microneedle patch for sustained analgesic delivery and chondroprotection in osteoarthritis

Article

Author: Wu, Qian ; Tran, Thi Bao Tram ; Truong, Cao-Sang ; Sakhrie, Aseno ; Pham, Hoang-Phuc ; Bhatt, Himanshu N ; Luong, Nha-Thi ; Nguyen, Thanh D ; Pahal, Suman ; Li, Zhiming ; Diwan, Rimpy

Osteoarthritis (OA) is a prevalent chronic condition characterized by persistent pain, necessitating sustained therapeutic interventions to manage symptoms effectively. In this study, we introduce a novel core-shell microneedle system for sustained release, termed Microneedle-based Integrated Release with Advanced Composite Layered Efficacy (MIRACLE). The design is a triple-layered microneedle (MN) patch engineered for the prolonged management of OA-associated pain. The patch consists of a 15 × 15 array within a 1 cm² area, featuring a specialized three-level architecture. One core-layer of the MIRACLE is designed to provide sustained controlled release of multiple pain drugs. One sub-shell layer is designed to prevent premature burst release (over-dosing) of the encapsulated payloads and an outermost layer is designed to ensure sufficient mechanical strength for skin penetration regardless of the core-layer drug formulation which is often tuned to obtain different sustained release profiles. Within an hour of application, an integrated effervescent layer (between the needle tips and backing layer) is rapidly dissolved and facilitates implantation of the MNs into the skin. Subsequently, the system provides a controlled, co-delivery of Bupivacaine (BUP) and Meloxicam (MEL), which act synergistically to provide sustained anesthetic and anti-inflammatory effects for up to 10 days (for comparison, the only commercial long-acting Zynrelef™ drug for post-operational pain only has up to 3-day acting period) in OA rat models. Besides the analgesic efficacy, the MIRACLE system demonstrated a significant capacity to mitigate articular cartilage degradation. This multi-layered MNs platform could represent an excellent strategy for not only the treatment of chronic osteoarthritis pain but also the management of other types of neuromusculoskeletal pains, offering a significant and broad impact on modern medicine.

01 Apr 2026·SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES

Use of Zynrelef (bupivacaine and meloxicam) to eliminate the need for opioids in laparoscopic pre-peritoneal inguinal hernia repairs

Article

Author: Beard, Timothy ; Devenny, Madison Linde ; Beard, Cameron A ; Masterangelo, Michael

BACKGROUND:

Inguinal hernia repairs are a common procedure, occurring in 800,000 patients across the United States and 20 million patients worldwide annually (Simmons et al. in Hernia 22:1-165, 2018;Knight et al. in Surgery 166:752-757, 2019;Schirle et al. in Syst Rev 9:139, 2020;). Currently, the most common form of pain management used by providers has been opioids despite unwanted side effects and dependence risk. Studies show up to 71% of patients undergoing TEP are prescribed opioids for pain management (Brummett et al. in JAMA Surg 152, 2017). The growing national misuse of opioids stresses the importance of alternative pain management options. Zynrelef has proven effective for managing post-op pain up to 72 h following several other surgeries but has not been effectively tested in TEP(s) (Hill et al. in Ann Surg 265:709-714, 2017; Provisional Drug Overdose Death Counts. National Vital Statistics System. Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.;Hamilton et al. in Anaesthesia 78:170, 2023;). This study observed opioid usage in patients following the use of Zynrelef during TEP procedures to determine if Zynrelef proves to be an effective alternative to opioid usage.

METHODS:

43 subjects (42 male and 1 female) between ages 32 and 79 years, scheduled to undergo TEP, were enrolled in the study and received between 7 and 14 mL's of Zynrelef prior to wound closure in the pre-peritoneal space via the most inferior 5 mm trocar. Subjects were instructed to take multimodal agents (Acetominophen1000 mg Q6 and Ibuprofen 800 mg q6) and given a prescription for opioids if their NRS pain score was greater than 6/10 in recovery. Subjects were then followed for 10 days after surgery to observe and record all medication usage and pain levels.

RESULTS:

39 subjects completed the study period (2 subjects excluded due to multiple hernias found during surgery and 2 lost to follow-up). 6 (15.4%) subjects received an opioid prescription, 33 (84.6%) did not. Mean pain immediately following surgery was 3.51 (SD ± 1.94), 2.63(SD ± 1.73) on POD1, 2.51(SD ± 1.57) on POD3, 2.00(SD ± 1.34) on POD5, and 1.11(SD ± 0.98) on POD 10. Mean discontinuation of acetaminophen and ibuprofen was 6.23 and 5.63 days post-op, respectively. Of the six subjects who received opioids post-op the mean time to opioid discontinuation was 5 days.

CONCLUSION:

Results of this study display adequate pain management following TEP procedures with the use of Zynrelef and a reduction in the use of opioids compared to patients undergoing TEP without Zynrelef. The findings from this study are in alignment with findings from other studies such as the HOPE trial in which Zynrelef was used in patients with open inguinal hernias and displayed an opioid-free rate of 91%.

25 May 2024·Journal of pain management and therapeutic care

Initial Experience with Bupivacaine-Meloxicam Extended Formulation (Zynrelef®) ForOpen Urologic Surgery

Article

Author: Quinn, A M ; Staniorski, C J ; Krampe, Y ; Sharbaugh, D ; Chelly, J E ; Yabes, J G ; Watts, A ; Vasan, R V ; Madhavaram, A ; Davies, B J ; Jacobs, B L ; Myrga, J M ; Pena, V N

Introduction:

The opioid epidemic has led to efforts to improve peri-operative pain control by using multiple modalities. The goal of this study was to evaluate the efficacy and safety of bupivacaine meloxicam extended formulation (Zynrelef^®) in open urologic surgery.

Materials and Methods:

Patients who received Zynrelef^® during open prostatectomy and nephrectomy were retrospectively reviewed from April 2022 through December 2022. Opioid consumption, patient reported pain, and complications were collected.

Results:

A total of 116 patients were included, 44 of whom received Zynrelef^® (38%). The groups were similar in terms of comorbidities and procedures. Fifty-nine patients (51%) underwent prostatectomy and fifty-seven underwent radical or partial nephrectomy (49%). Morphine milligram equivalents decreased over the first three post-operative days in both groups. The largest difference in opioid consumption between the Zynrelef^® group vs the control group occurred on post-operative day 2, with patients in the with Zynrelef^® group consuming fewer narcotics (median morphine milligram equivalents 8 vs. 15, standardized bias 0.38). Patient reported pain on post-operative day 1 was clinically similar in the Zynrelef^® group vs the control group (5 vs. 4 on 10-point scale) while post-operative calls to the office (34% vs. 19%) and emergency visits (11% vs. 1%) were increased in those receiving Zynrelef^®. Three wound infections occurred in the Zynrelef^® group (7%), all following prostatectomy with none occurring in the control group.

Conclusions:

Zynrelef^® administration following urologic procedures may decrease opioid requirements post-operatively. However, the rate of wound infections, emergency visits, and postoperative calls may be increased compared to standard methods of pain control.

News (Medical) associated with Bupivacaine/Meloxicam

22 Jul 2026

·www.ventouxbio.com

Encouraging Progress In Our Dupuytren’s Research

Ventoux Bio July 22, 2026 Dupuytren's Information, Events We have now studied VEN-201 in human Dupuytren’s tissue from several individual donors, and the early results are genuinely encouraging. Across these samples, VEN-201 has shown consistent signs of acting on the biological processes that drive the disease, exactly the direction we hoped to see. What gives us particular confidence is that consistency. Seeing the same direction of effect across tissue from different people, despite the natural variation from one person to the next, is an important early signal that we may be engaging the true drivers of the disease rather than seeing a one-off result. It is still early, and there is real work ahead before this reaches patients, but this is the kind of human-anchored evidence that strengthens our conviction and helps open doors with research and funding partners. Out of respect for the scientific process, we are sharing these findings at a high level for now, with more detail to follow as the work matures. Our focus now is to build on these findings: studying additional donor tissue to further test what we are seeing, deepening our understanding of how VEN-201 works, and advancing the preparation needed to move toward a first clinical study. Each of these steps brings us closer to testing VEN-201 in patients, and each one depends on continued support. This is the question closest to my own heart and the one I receive the most from fellow patients. Our current estimate is roughly 18 months to a first clinical study, and reaching that milestone depends heavily on funding. Here is the honest part. Dupuytren’s affects millions of people, yet it has long been underfunded for how common and life-altering it is, and today’s climate is especially hard for early-stage research. Many investors now wait to commit until a therapy is already being tested in humans, which leaves promising pre-clinical programs like ours in a real gap. We are pushing hard to reach that in-human stage, and it is truly within sight. That final stretch is where community support matters most. Any and all help, whether you run with me, donate, or invest, moves us from promising science into the clinic and closer to the day patients can join a study. There are three ways to be part of this, whichever fits you best: Run with Me. This October I am running the 25k at the Lake Hodges Trail Festival in San Diego and I would love for you to join our team and run with me. Our team name is the Dupuytren’s & Ledderhose Run Collective, more info below. Donate. If you would rather cheer from the sidelines (near or far), every dollar donated does directly to our Dupuytren’s research at Ventoux Biosciences. Please donate and / or share with fellow patients impacted by this disease. Invest. We have a crowdfunding campaign now open and anyone can invest. WeFunder is a regulated investment crowdfunding platform where everyday investors can invest in Ventoux and receive equity, an ownership stake in the company, rather than making a donation. Investment minimum is $100. Company News Dupuytren's Information Events Johnny Randel is a senior finance executive who has more than 30 years of experience in financial institutions including over 17 in private equity. Mr. Randel recently retired as the Chief Financial Officer (“CFO”) of StepStone Group. Inc (Nasdaq: STEP), a global private markets specialist firm delivering tailored investment solutions, advisory services, and impactful, data-driven insights to the world’s investors with $678B of capital responsibility. Mr. Randel spent over 13 years leading the corporate and investment finance and accounting teams and was the CFO for the lead up and execution of the company’s initial public offering in 2020. Previously, Mr. Randel held the role of Chief Financial Officer and Chief Operating Officer at Citigroup Private Equity overseeing financial and operational activities for the company and its coinvestment, mezzanine, and fund of fund investment programs. Mr. Randel also held a previous role as Assistant Treasurer within Citigroup Inc.’s Treasury department where he managed rating agency relationships and fixed income client relations. Mr. Randel also held various finance roles supporting corporate finance and strategy over the course of his career. Mr. Randel received his B.G.S. from the University of Kansas and MBA from the University of Southern California. Mr. Cravets is an industry leader in biostatistics with extensive experience in program design and analysis. He currently serves as the Senior Vice President of Biometrics at Gossamer Bio. Prior to joining Gossamer Bio, Mr. Cravets was Vice President of Biometrics at Heron Therapeutics Inc. from 2016 to 2018, where he played a key role in the late-stage development programs for Zynrelef for the treatment post-surgical pain and Cinvanti for the prevention of chemotherapy induced nausea and vomiting. Before joining Heron, Mr. Cravets was Executive Director of Biometrics at Receptos Inc. from 2014 to 2016, where he built the biostatistics and data management functions while contributing to mid- and late-stage development programs for ozanimod (Zeposia) in multiple sclerosis (MS) and inflammatory bowel diseases (IBD). Before joining Receptos, Mr. Cravets was the head of biostatistics at Ardea Biosciences from 2011-2014, building the biostatistics function while also making significant contributions to the designs and analyses of late-stage studies of lesinurad (Zurampic) for the treatment of gout. From 2003-2011 Mr. Cravets served in roles of increasing responsibility in the biostatistics group at Biogen Idec Inc., contributing to the successful regulatory approvals of rituximab (Rituxan) in both rheumatoid arthritis (RA) and chronic lymphocytic leukemia (CLL). From 1996 to 2003, Mr. Cravets was in the biostatistics group at Amgen, Inc., working on multiple products across various neurology, rheumatology, cardiovascular, and bone disease indications. Mr. Cravets began his career in the pharmaceutical products division of Abbott Laboratories in 1994 after completing his master’s degree in statistics at the University of Michigan and his bachelor’s degree in mathematics at UCLA. Dr. Satish is a trained biotechnologist with several years of experience in cell and molecular biology. Dr. Satish’s interest has been in skin research with a special focus on skin inflammation, infection, and fibrosis. The other arm of Dr. Satish’s research has been to study the molecular determinants of palmar fascial disease, Dupuytren’s contracture. Her long-term interest has been to develop therapeutic agents to help alleviate the pain and distress of patients with Dupuytren’s. Her studies on Dupuytren’s disease were funded by a private donor, which moved the research forward to study this disease in an animal model, which was not feasible earlier. Dr. Satish’s research on Dupuytren has identified small molecules that can be used as a target to intervene with the progression and development of the disease. Dr. Satish received her Ph.D. from a prestigious institute in India and did her post-doctoral training at the University of Pittsburgh. Currently, Dr. Satish serves as a faculty at the Division of Asthma Research, Cincinnati Children’s Hospital; named as the top hospital in the US. At Cincinnati Children’s, Dr. Satish researches Atopic Dermatitis, a chronic inflammatory skin disease affecting children and adults. Dr. Satish has published over 50 articles in peer-reviewed journals, review articles and book chapters. Dr. Denkler is an accomplished, board certified plastic surgeon with expertise in aesthetic and reconstructive surgery. Dr. Denkler is a clinical professor of plastic surgery at UCSF and has a private practice in Marin County. He is internationally renowned for his use of multiple approaches in treating the debilitating and disabling effects of palmar fibromatosis (Dupuytren disease). Dr. Denkler is an expert in needle aponeurotomy (NA), a minimally invasive procedure that uses subcutaneous needles to release the contracture as well as use of subcutaneous injection of collagenase. He has treated over 10,000 Dupuytren’s fingers, authored >35 publications and book chapters, presented internationally and domestically and is often cited for expert opinion in national and international news discussing Dupuytren’s. HIs pioneering investigational work documenting the safety of epinephrine with local anesthesia contributed to the origination of “wide-awake hand surgery”. Dr. Denkler trained at prestigious medical institutions in the United States and Europe. He attended Baylor College of Medicine in Houston, Texas, followed by residency training in plastic and reconstructive surgery with the Cronin, Bauer, and Biggs group, also in Houston. Additionally, Dr. Denkler completed a hand surgery fellowship with Dr. Eugene Kilgore in San Francisco and one year of fellowship training in craniofacial surgery with Dr. Paul Tessier in Paris, France. Daiva Bajorunas MD is an endocrinologist with more than 25 years of experience in the biopharmaceutical industry. She has a strong interest in advancing therapeutic options for conditions of significant unmet medical need. For the past decade, Daiva has been engaged as a consultant to the pharmaceutical industry, currently as Founder and Principal, DBMD Consulting, and previously as Chief Medical Officer / Chief Scientific Officer for Vault Bioventures. She has provided her expertise to enhance large, mid-size and small pharmaceutical company product development, clinical/regulatory, and life cycle strategies for both drugs and devices, including oral, transdermal, injectable and inhalative delivery systems, working across multiple therapeutic areas and geographies. She has considerable experience chairing Data Safety Monitoring Boards. In the past she held various R&D positions of increasing responsibility at Rhone-Poulenc Rorer, BMS, Aventis (acquired by Sanofi), and Kos Pharmaceuticals (acquired by Abbott). Before she joined industry, she held academic appointments at Memorial Sloan-Kettering Cancer Center and Cornell University Medical College (CUMC), and was Director of Clinical Care, Endocrinology Service, Memorial Hospital (MH), New York, NY. Daiva received her MD degree at the University of Michigan Medical School, did her residency training at St. Vincent’s Hospital & Medical Center in NY, her metabolism fellowship at Stanford University Medical Center, CA and her endocrinology fellowship at MH/CUMC, NY.

Executive Change

09 Jan 2026

·ir.herontx.com

Heron Therapeutics Announces Preliminary, Unaudited Q4 and Full-Year 2025 Net Revenue; ZYNRELEF® Largest Contributor to Q4 Growth

CARY, N.C., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (“Heron” or the “Company”), a commercial-stage biotechnology company, today announced preliminary, unaudited fourth quarter and full-year 2025 net revenue. “We are encouraged by the growth in Q4 2025, driven in particular by the momentum in our Acute Care franchise with ZYNRELEF® and APONVIE®,” said Craig Collard, Chief Executive Officer of Heron. “In addition to our revenue growth, we are extremely pleased with the continued progress made across all aspects of our business throughout the past year.” Preliminary Fourth Quarter and Full Year 2025 Updates Net revenue of approximately $40.5 million for the three months ended December 31, 2025. ZYNRELEF® net revenue of approximately $12.5 million for the three months ended December 31, 2025. APONVIE® net revenue of approximately $3.8 million for the three months ended December 31, 2025. CINVANTI® net revenue of approximately $22.9 million for the three months ended December 31, 2025. SUSTOL® net revenue of approximately $1.3 million for the three months ended December 31, 2025. Net revenue of approximately $154.9 million for full-year 2025. ZYNRELEF® delivered the largest quarter-over-quarter revenue increase within the portfolio in Q4 (up ~35% vs Q3 2025). ZYNRELEF® net revenue of approximately $12.5 million for the three months ended December 31, 2025. APONVIE® net revenue of approximately $3.8 million for the three months ended December 31, 2025. CINVANTI® net revenue of approximately $22.9 million for the three months ended December 31, 2025. SUSTOL® net revenue of approximately $1.3 million for the three months ended December 31, 2025. About ZYNRELEF® for Postoperative Pain ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com. About APONVIE® for Prevention of Postoperative Nausea and Vomiting (“PONV”) Prevention APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for the prevention of PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at www.APONVIE.com. About CINVANTI® for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at www.CINVANTI.com. About SUSTOL® for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at www.SUSTOL.com. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com. Forward-Looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this news release other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercialization strategy as well as plans and objectives of management for future operations, are forward-looking statements. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. The estimated preliminary financial results for the fourth quarter and fiscal year ended December 31, 2025 contained in this press release contain forward-looking statements that are based on information available to the Company as of the date of this release. The Company’s financial closing and review procedures for the fourth quarter and full year 2025 are not yet complete, and actual results may differ from these preliminary estimates as a result of final accounting adjustments, the completion of internal control processes, and other developments that may arise prior to the finalization of the Company’s financial statements. The preliminary financial results included in this release have not been audited or reviewed by the Company’s independent registered public accounting firm and should not be considered a substitute for the Company’s full interim or annual financial statements. Accordingly, undue reliance should not be placed on this preliminary information. Forward-looking statements include, among others, statements we make regarding the estimated preliminary financial results referred to above, the potential market opportunities for ZYNRELEF®, APONVIE®, CINVANTI® and SUSTOL®; revenue, adjusted EBITDA and other financial guidance provided by the Company; interim financial data or prescription data, which may not necessarily be indicative of quarterly or annual results; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system or launch of the ZYNRELEF VAN; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink Network, LLC; the outcome of the Company's pending patent litigations, including potential appeals of any verdicts and the settlement described herein; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; the terms and conditions, completion of the refinancing transactions, and the anticipated proceeds and use of proceeds of the refinancing transactions; any inability or delay in achieving profitability, including as a result of regulatory developments and policy changes in the U.S. and other jurisdictions. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. iduarte@herontx.com 858-251-4400

Phase 3Drug ApprovalFinancial StatementClinical Result

04 Nov 2025

·ir.herontx.com

Heron Therapeutics Announces Q3 2025 Financial Results and Highlights Commercial Progress

Generated Q3 2025 Net Revenue of $38.2 million and year-to-date revenue of $114.3 million; reaffirmed 2025 Net Revenue Guidance of $153 million - $163 million and adjusted EBITDA of $9.0 - $13.0 million ZYNRELEF® Net Revenue grew 49% in Q3 2025, as compared to Q3 2024, continuing momentum with the launch of the Vial Access Needle (VAN) and enhanced incentive program with key distributors APONVIE® Net Revenue grew 173% in Q3 2025, as compared to Q3 2024, supported by increased adoption and momentum building with the newly launched dedicated sales team in Q3 2025 CARY, N.C., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (“Heron” or the “Company”), a commercial-stage biotechnology company, today announced financial results for the three and nine months ended September 30, 2025 and recent corporate updates. “There were a number of new initiatives launched in the third quarter, and we’re encouraged by the early signs that they’re positively impacting our commercial execution and driving increased demand for our products,” said Craig Collard, Chief Executive Officer of Heron. Financial Guidance for 2025 Business Highlights Heron’s Acute Care franchise delivered revenue growth of 67.2% year-over-year in Q3 2025 and 69.2% year-over-year for the first nine months of 2025, reflecting continued commercial acceleration. ZYNRELEF Updates: ZYNRELEF Net Revenue increased $3.1 million or 49% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $8.5 million or 49% in the nine months ended September 30, 2025 compared to the same period in 2024. Commercial initiatives include launch of a reorganized, dedicated ZYNRELEF sales team in Q3 2025, and enhanced distributor incentives in select accounts – including both formulary and high potential non formulary accounts – to drive growth and accelerate adoption. Following a phased roll-out, transition to the VAN is complete, and every unit of ZYNRELEF now includes this enhanced device - optimizing product preparation, handling and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across U.S. The permanent, product specific J-code for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services, went live effective October 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care. The ZYNRELEF Prefilled Syringe program is progressing. Stability for this proposed market presentation has commenced and, if successful, approval is anticipated in 2027. APONVIE Updates: APONVIE Net Revenue increased $1.9 million or 173% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $5.2 million or 200% in the nine months ended September 30, 2025 compared to the same period in 2024. We enter Q4 2025 with a seasoned and fully trained APONVIE team leveraging the full range of Heron’s resources to drive adoption within the many health systems and accounts achieved since launch. Oncology Updates: CINVANTI unit demand and Net Revenue increased 6% in Q3 as compared to Q3 2024, continuing to hold consistent revenue year-over-year. Cash, cash equivalents, and short-term investments were $55.5 million as of September 30, 2025. ZYNRELEF Net Revenue increased $3.1 million or 49% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $8.5 million or 49% in the nine months ended September 30, 2025 compared to the same period in 2024. Commercial initiatives include launch of a reorganized, dedicated ZYNRELEF sales team in Q3 2025, and enhanced distributor incentives in select accounts – including both formulary and high potential non formulary accounts – to drive growth and accelerate adoption. Following a phased roll-out, transition to the VAN is complete, and every unit of ZYNRELEF now includes this enhanced device - optimizing product preparation, handling and operating field sterility with ZYNRELEF in hospitals and ambulatory surgical centers across U.S. The permanent, product specific J-code for ZYNRELEF, granted by the Centers for Medicare and Medicaid Services, went live effective October 1, 2025 – streamlining reimbursement and improving billing clarity across payer types and settings of care. The ZYNRELEF Prefilled Syringe program is progressing. Stability for this proposed market presentation has commenced and, if successful, approval is anticipated in 2027. APONVIE Net Revenue increased $1.9 million or 173% in the three months ended September 30, 2025, compared to the same period in 2024, and increased $5.2 million or 200% in the nine months ended September 30, 2025 compared to the same period in 2024. We enter Q4 2025 with a seasoned and fully trained APONVIE team leveraging the full range of Heron’s resources to drive adoption within the many health systems and accounts achieved since launch. CINVANTI unit demand and Net Revenue increased 6% in Q3 as compared to Q3 2024, continuing to hold consistent revenue year-over-year. Conference Call and Webcast Heron will host a conference call and live webcast on Tuesday, November 4, 2025, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron's website for sixty days following the call. About ZYNRELEF® for Postoperative Pain ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com. About APONVIE® for Prevention of Postoperative Nausea and Vomiting (“PONV”) Prevention APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at www.APONVIE.com. About CINVANTI® for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at www.CINVANTI.com. About SUSTOL® for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at www.SUSTOL.com. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com. Non-GAAP Financial Measures To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting. In our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but that we do not believe are indicative of ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted EBITDA excludes depreciation and amortization and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; and adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments. For a reconciliation of such non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with GAAP, please see the table titled “U.S. GAAP to Non-GAAP Reconciliation” below. Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this news release other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercialization strategy as well as plans and objectives of management for future operations, are forward-looking statements. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; revenue, adjusted EBITDA and other financial guidance provided by the Company; interim financial data or prescription data, which may not necessarily be indicative of quarterly or annual results; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system or launch of the ZYNRELEF VAN; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink Network, LLC; the outcome of the Company's pending patent litigations, including potential appeals of any verdicts and the settlement described herein; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; the terms and conditions, completion of the refinancing transactions, and the anticipated proceeds and use of proceeds of the refinancing transactions; any inability or delay in achieving profitability, including as a result of regulatory developments and policy changes in the U.S. and other jurisdictions. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: Ira DuarteExecutive Vice President, Chief Financial OfficerHeron Therapeutics, Inc.iduarte@herontx.com858-251-4400

Phase 3Drug ApprovalFinancial Statement

100 Deals associated with Bupivacaine/Meloxicam

External Link

KEGG	Wiki	ATC	Drug Bank
D12270	-	M01AC56 N01BB59 N01BB51	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain, Postoperative	European Union	Heron Therapeutics, Inc.	24 Sep 2020
Pain, Postoperative	Iceland	Heron Therapeutics, Inc.	24 Sep 2020
Pain, Postoperative	Liechtenstein	Heron Therapeutics, Inc.	24 Sep 2020
Pain, Postoperative	Norway	Heron Therapeutics, Inc.	24 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 3	United States	Heron Therapeutics, Inc.	04 Apr 2019
Bunion	Phase 2	United States	Heron Therapeutics, Inc.	01 May 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03955211 (CTgov)	Phase 2	Pain, Postoperative	25	ZYNRELEF kit components for administration+HTX-011 (HTX-011 300 mg/9 mg)	bbyalrvjoo(rprdcmbgsx) = pzzhuzerlx ufodcusljd (sigzptlali, 59.5) View more	-	27 Oct 2026
				ZYNRELEF kit components for administration+HTX-011 (HTX-011 400 mg/12 mg + MMA)	bbyalrvjoo(rprdcmbgsx) = mnkfcgmrjx ufodcusljd (sigzptlali, 69.6) View more
NCT06109415 (AMAZE, CTgov)	Phase 4	Analgesia \| Pain, Postoperative	30	ZYNRELEF kit components for administration+HTX-011 (HTX-011 + MMA)	uzizildzag = ockirqgfda ldnymsawow (ykeivvzahu, fmadgrhkqh - soonpcunnr) View more	-	27 Oct 2026
				MMA regimen+Bupivacaine Hydrochloride (Bupivacaine HCl + MMA)	uzizildzag = wplvkrfvse ldnymsawow (ykeivvzahu, ofsghwouoy - iixscmqgnh) View more
NCT03907176 (CTgov)	Phase 3	Analgesia	209	Luer lock applicator+Acetaminophen+Ibuprofen+HTX-011 (HTX-011 + Alternating MMA Regimen)	wlfqycxufx = dojglgzexx ulsxqasydo (raccjpjmyj, ljupqpgunt - klubxqwssy) View more	-	04 Jun 2026
				Luer lock applicator+Acetaminophen+Ibuprofen+HTX-011 (HTX-011 + Concurrent MMA Regimen)	wlfqycxufx = xxcprtqqjl ulsxqasydo (raccjpjmyj, vdykttqhvr - aesayabfau) View more
NCT05188053 (CTgov)	Phase 4	-	209	HTX-011 (HTX-011 Treatment Group)	bdhjhcyieb(snxmntdbrm) = rdfskahodk tprwwiyatv (lzuhfdibvg, 16) View more	-	27 Apr 2025
				epinephrine+ropivacaine+ketorolac (Standard Block Control Group)	bdhjhcyieb(snxmntdbrm) = sbcurltcrb tprwwiyatv (lzuhfdibvg, 21) View more
NCT03974932 (CTgov)	Phase 3	Analgesia	116	Luer Lock Applicator+Acetaminophen+Ibuprofen+HTX-011	goniivzoze(nexeyajnnh) = hfkympyvik chamjwyjlp (urpyzauklq, 118.431) View more	-	31 Aug 2023
NCT03718039 (CTgov)	Phase 2	Pain, Postoperative	78	Luer Lock applicator+HTX-011 (Treatment Group 1: HTX-011)	dagzdlnlho(raljrwmumf) = wqgwugwixa nhiuoilkko (pbibwbxivk, 151.085) View more	-	26 Jun 2023
				Luer Lock applicator+aprepitant+HTX-011 (Treatment Group 2: HTX-011 + Aprepitant)	dagzdlnlho(raljrwmumf) = oiykxlvgdh nhiuoilkko (pbibwbxivk, 115.790) View more
NCT03955211 (Corporate Publications) Manual	Phase 2	-	25	HTX-011	gytsqinmoz(daxejkekgu) = ildyufvxbe fgcpluxjtx (gdrhyeiiqv ) View more	Positive	16 May 2022
				multimodal analgesia+HTX-011	gytsqinmoz(daxejkekgu) = vzeepoximg fgcpluxjtx (gdrhyeiiqv ) View more
NCT03011333 (CTgov)	Phase 2	Pain, Postoperative	243	HTX-011 (Group 1: HTX-011)	duonwcfldt(edcowihfan) = eiisptdypk ylpfgqgzmr (bpidydpaus, 59.462) View more	-	29 Oct 2021
				HTX-011 (Group 2: HTX-011)	duonwcfldt(edcowihfan) = jfrmtqokqv ylpfgqgzmr (bpidydpaus, 58.598) View more
NCT03015532 (CTgov)	Phase 2	Pain, Postoperative	285	HTX-011 (Cohort 1, Group 1: HTX-011)	rnrqapmdpb(tzyblvbovr) = ipyqnjrslj rdzttbzhin (bbeiyrthij, 82.930) View more	-	27 Oct 2021
				HTX-011 (Cohort 1, Group 2: HTX-011)	rnrqapmdpb(tzyblvbovr) = oczwhekdzm rdzttbzhin (bbeiyrthij, 84.450) View more
NCT03237481 (EPOCH 2, CTgov)	Phase 3	Pain, Postoperative	418	Luer-lock applicator+HTX-011 (Treatment Group 1: HTX-011)	mlrdmtekgx(udvteidlai) = dmokahbsjf rkvauiymqb (cejpsnbqpr, 173.719) View more	-	27 Oct 2021
				Saline placebo (Treatment Group 3: Saline Placebo)	mlrdmtekgx(udvteidlai) = mdnvhamjjk rkvauiymqb (cejpsnbqpr, 171.224) View more

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