Heron Therapeutics (HRTX) to Present Statistically Significant HTX-011 Phase 2 Data at PAINWeek
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Heron Therapeutics, Inc. (Nasdaq: HRTX) announced that results from the initial portions of Heron’s Phase 2 study of HTX-011 in patients undergoing inguinal hernia repair (Study 202) will be presented today in two posters at PAINWeek®, the national conference on pain for frontline practitioners, in Las Vegas, NV. The posters were co-authored by Harold S. Minkowitz, MD, Diplomat American Board of Anesthesiology, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center and Peter J. Winkle, MD, FACP, CPI, FACG, Anaheim Regional Medical Center, Anaheim Clinical Research.
Study 202 was a randomized, placebo-controlled, double-blind Phase 2 clinical study in patients undergoing inguinal hernia repair. The study evaluated the efficacy and safety of three formulations of HTX-011 and two routes of administration into the wound (injection and instillation). Instillation into the incision site is an easier and potentially safer route of administration as it avoids multiple injections around the wound (as many as 10 or more in large operations) that carry the risk of venous puncture.
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). Important secondary endpoints included SPI for the first 48 hours post-surgery, total opioid consumption, and the percent of patients opioid-free through 96 hours post-surgery. Today’s presentations describe Part B of the study (202B), which compared our planned Phase 3 formulation of HTX-011 (HTX-011B) at 200 mg (n=30) and 400 mg (n=30) to saline placebo (n=31). The major findings for the 400 mg dose of HTX-011B as compared to placebo are as follows:
- There was a 29.5% reduction in pain as measured by SPI 0-24 (p=0.0035).
- Instillation (29.9% reduction in SPI 0-24) was equally as effective as injection (29.1% reduction in SPI 0-24).
- The pain reduction was long-lasting, with a statistically significant, 25.2% reduction through 48 hours (SPI 0-48; p=0.0250).
- Mean total opioid consumption decreased by 22.4% through 96 hours post-surgery.
- The number of patients who were opioid-free through 96 hours post-surgery was substantially higher (24.1% versus 6.5%).
HTX-011 has been generally well tolerated in the ongoing Phase 2 program, which has involved more than 250 administrations of HTX-011. In Study 202B, the frequency of treatment-related adverse events reported was 38.7% in the HTX-011B 200 mg group, 33.3% in the HTX-011B 400 mg group, and 51.6% in the placebo group. The most frequent treatment-related adverse events reported were nausea, constipation and headache.
"I have been working in acute pain research for 25 years and I have worked with many new products. I am extremely impressed with the efficacy of HTX-011,” commented Harold S. Minkowitz, MD, Diplomat American Board of Anesthesiology, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center. “Additionally, the unique ability to instill HTX-011 with equal efficacy to a standard infiltration technique provides a fast, easy and safe route of administration.”
“The results presented today give us confidence as we prepare for our broad-based Phase 3 registration program,” commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. “We remain focused on our goal of delivering a therapeutic tool that can not only greatly reduce pain levels following surgery, but also reduce the burden of opioids.”
PAINWeek® 2016 Posters
Heron’s posters from PAINWeek® 2016 are available on Heron’s website (www.herontx.com) under Scientific Posters and Presentations under the following titles:
- Local Administration of HTX-011, a Long-Acting Biochronomer®-Based Bupivacaine/Meloxicam Combination, in Hernia Repair: Preliminary Results of an Interim Analysis
- Local Administration of HTX-011, a Long-Acting Biochronomer®-Based Bupivacaine/Meloxicam Combination, in Hernia Repair Provides Similar Initial Results Whether Injected or Instilled
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