Heron soars after its painkiller agent reduces pain and opioid use post-surgery at Phase 3
pharmafile | March 20, 2018 | News story | Manufacturing and Production, Research and Development | heron therapeutics, opioid crisis, opioid epidemic, opioids, painkiller, pharma
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
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