Health

Heron Therapeutics Has Positive Results From Phase 3 Bunionectomy and Hernia Repair Drug

March 19, 2018

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3 min read

Heron Therapeutics (Nasdaq: HRTX) announced positive topline results from its completed Phase 3 studies of its product candidate HTX-011 in patients undergoing bunionectomy and hernia repair. HTX-011 achieved all primary and key secondary endpoints in both Phase 3 trials, demonstrating statistically significant reductions in pain intensity and the use of opioid rescue medications through 72 hours following surgery.

HTX-011 is the first and only long-acting local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control, through 72 hours.

Source: Heron Therapeutics, March 19, 2018

Heron’s HTX-011 showed positive results in the primary endpoint of

pain intensity from 0 to 72 hours post-surgery compared to placebo

as well as all secondary endpoints of

comparison of AUC 0-72 of pain intensity to bupivacaine solution
the total amount of opioid rescue medication consumption compared to placebo through 72 hours after surgery
the proportion of patients who received no opioid rescue medication after surgery compared to bupivacaine solution
the total opioid consumption through 72 hours after surgery compared to bupivacaine.

Summary table:

Source: Data from Heron Therapeutics. Chart by Equities.com

HTX-011 was well tolerated in both studies, with a safety profile comparable to placebo and bupivacaine solution. There were no drug-related serious adverse events or discontinuations due to drug-related adverse events in HTX-011-treated patients, and there were fewer opioid-related adverse events in HTX-011-treated patients.

HTX-011 is the first and only long-acting anesthetic designed to address both postoperative pain and inflammation in a single administration at the surgical site. The unique synergy of bupivacaine and meloxicam in HTX-011 has consistently been shown to reduce pain over 72 hours significantly better than bupivacaine alone in multiple diverse surgical models. HTX-011 is administered as a single-dose application via needle-free syringe to directly coat the affected tissue within the surgical site prior to suturing, which makes HTX-011’s route of administration faster, easier and potentially safer compared to numerous injections required with current local anesthetics.

With today’s results, HTX-011 is the only locally administered anesthetic to demonstrate superior pain relief and a reduction in opioid use as compared to not only placebo, but also the current standard-of-care, bupivacaine solution, in Phase 3 studies. We look forward to submitting a New Drug Application for HTX-011 to the U.S. Food and Drug Administration in the second half of 2018. If approved, we believe that HTX-011 could have a significant impact on the opioid crisis by reducing the use of opioids after surgery, while at the same time allowing patients to experience less pain.

– Barry D. Quart, Pharm.D., CEO, Heron Therapeutics.