Heron’s anesthetic aces phase 2 trials, reducing opioid use, and nabs FDA breakthrough designation | Tech News
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.
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%.
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.