Heron’s anesthetic aces phase 2 trials, reducing opioid use, and nabs FDA breakthrough designation

Heron Therapeutics posted new positive results for its long-acting anesthetic for postoperative pain, HTX-011, this time from two phase 2b studies demonstrating effectiveness following total knee replacement and breast augmentation surgeries.

The data joins successful phase 3 findings in bunionectomy and hernia repair released earlier this year—sending the company’s stock up about 30% in premarket trading, as Heron also announced it received a Breakthrough Therapy designation from the FDA and reiterated that it’s on track to file an NDA before the end of the year.

As it had in previous studies, HTX-011 significantly reduced the amount of opioid medication needed as the patient recovered from the procedure, both when administered locally and as a nerve block. The Redwood City, California-based company’s drug is an extended-release formulation of the local anesthetic bupivacaine, combined with the anti-inflammatory meloxicam.

“With postoperative opioids serving as a gateway to addiction, there is a large unmet need for non-opioid pain alternatives,” said Heron CEO Barry Quart, citing HTX-011’s positive results from seven clinical studies across five surgery types.

“HTX-011 is the only long-acting local anesthetic to demonstrate significantly reduced postoperative pain and opioid use through 72 hours compared to bupivacaine solution, the standard-of-care local anesthetic for postoperative pain management, in phase 3 studies,” Quart added.

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In the knee arthroplasty study, the drug met its primary and secondary endpoints in reducing overall pain intensity compared to placebo in the days following surgery. When combined with a low dose of the anesthetic ropivacaine (Naropin), an HTX-011 instillation reduced pain intensity at rest by 22% after 72 hours compared to placebo, and by 19% with HTX-011 alone. Both outperformed standard-of-care bupivacaine’s reductions of 11%.

More conservative assessments, which measured pain with activity and movement, also saw stronger reductions with HTX-011: 16% and 12% with the combination and alone, respectively, compared to bupivacaine’s 4%.

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When administered as an instillation or pectoral nerve block before breast augmentation surgery, HTX-011 reduced pain intensity at rest by 22% through 24 hours following surgery. With activity, pain was reduced by 23% to 24%, again nearly doubling bupivacaine’s performance.

The instillation and nerve block reduced total opioid use by 33% and 26%, respectively, compared to placebo, much higher than a bupivacaine nerve block, which saw reductions of 10%.

Jefferies analysts previously estimated that HTX-011, which has also received Fast Track status from the FDA, would reach $545 million in peak sales if it is approved with a superiority claim to generic bupivacaine on its label in certain indications, something other formulations may lack.