Heron Therapeutics Reports Positive Top-Line Results from Phase 2 Study of HTX-011 in the Management of Post-Operative Pain

Heron Therapeutics, Inc.

, a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today announced positive, top-line results from its Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. The primary and all key secondary endpoints in the study were met with a high degree of statistical significance. This randomized, placebo-controlled, double-blind, Phase 2 clinical study in 64 patients undergoing bunionectomy evaluated the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. The primary endpoint was the difference as compared to placebo in pain intensity as measured by the Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24). Key secondary endpoints included: the difference in SPI in the first 48 hours post-surgery (SPI 0-48); the difference in SPI in the first 72 hours post-surgery (SPI 0-72); time to the first use of opiate rescue medication; and the percent of patients who received no opiate rescue medication in the first 72 hours post-surgery. The study's major efficacy findings for the more effective, 400 mg dose of HTX-011 as compared to placebo include: Pain intensity in the first 24 hours post-surgery was reduced by 69% (SPI of 38.5 versus 124.2, p<0.0001). Pain intensity in the first 48 hours post-surgery was reduced by 52% (SPI of 106.9 versus 224.8, p<0.0001). Pain intensity in the first 72 hours post-surgery was reduced by 40% (SPI of 170.2 versus 285.9, p=0.0064). Time to the first use of opiate rescue medication was increased by 488% (48.2 hours versus 8.2 hours, p<0.0001). 32% of patients received no opiate rescue medication during the entire 72-hour period post-surgery, compared to 5% for placebo (p<0.0001). HTX-011 was generally well tolerated in the study. The most frequent adverse events reported were headache, nausea, vomiting, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related. "Although opioid analgesics are standard of care for post-operative pain management, too often they are associated with unacceptable adverse effects often prolonging hospitalization and recovery," stated Jeffrey A. Gudin, MD, Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, Englewood, NJ. "Thus, there is a major unmet need for a pain management treatment that can substantially reduce our dependence on post-operative opioids. The ability of HTX-011, administered once during surgery, to significantly reduce pain and the need for pain medications for three days following surgery (as compared to a control group) is truly promising." "At Heron, we are dedicated to the development of best-in-class medicines that can have a major impact on patients' lives," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "We are very pleased with these results, and we now will turn our attention to executing on a broad-based development program designed to enable us to bring HTX-011 to the many patients undergoing a wide range of surgeries who experience significant post-operative pain." Conference Call and Webcast Heron Therapeutics will host a conference call and webcast on Wednesday, September 23 at 8:30 a.m. ET (5:30 a.m. PT). The conference call can be accessed by dialing (877) 311-5906 for domestic callers and (281) 241-6150 for international callers. Please provide the operator with the passcode 46461973 to join the conference call. The conference call will also be available via webcast under the investor relations section of Heron's website at www.herontx.com and will be archived there for 90 days following the call. Please connect to Heron's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.