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

Showed reduced pain and reduced opioid medication use post surgery.

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

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.

Source: Heron Therapeutics, March 19, 2018

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