Skip to NavigationSkip to content

Heron soars after its painkiller agent reduces pain and opioid use post-surgery at Phase 3

Published on 20/03/18 at 10:39am

Heron Therapeutics has been buoyed by the news that its painkiller agent HTX-011 met all of its primary and secondary endpoints in Phase 3 studies investigating its efficacy in relieving pain and opioid use in patients undergoing bunionectomy and hernia repair, sending its shares soaring by up to 32%.  

According to Heron, HTX-011 is “an extended-release formulation of the local anaesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain.”

In two Phase 3 trials including more than 800 patients, the therapy demonstrated significant reductions in pain intensity and the use of opioid-based ‘rescue’ medication in the 72 hours following surgery – the first long-acting anaesthetic to do so, according to the company.

HTX-011 use was shown to produce a pain reduction of 27% versus placebo, and 18% compared to standard-of-care bupivacaine solution, while opioid use dropped 37% compared to placebo and 25% compared to bupivacaine. 29% of patients who were given the therapy required no opioids at all throughout the 72-hour period, compared to 2% taking placebo and 11% on bupivacaine.

“With today’s results, HTX-011 is the only locally administered anaesthetic 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,” said Barry D Quart, Chief Executive Officer of Heron Therapeutics. “We look forward to submitting a New Drug Application for HTX-011 to the US 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.”

Matt Fellows

Mission Statement is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches