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
Related Content
FDA accepts new drug application for Orexo’s opioid overdose medication
Orexo has announced that its New Drug Application (NDA) for OX124 has been accepted for …
FDA approves IMIDEX’s AI-powered device VisiRad XR
The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …
Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo
On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …
