Heron says drug for post-surgery pain succeeds in midstage trial

Reuters Health Information: Heron says drug for post-surgery pain succeeds in midstage trial

Heron says drug for post-surgery pain succeeds in midstage trial

Last Updated: 2017-01-04

By Reuters Staff

(Reuters) - Heron Therapeutics Inc on Wednesday said its experimental combination drug for postoperative pain led to significant reductions in pain intensity and need for opioids, according to initial data from a midstage trial.

Heron shares jumped more than 8 percent in extended trading after the results were released.

The drug, HTX-011, which combines a long-acting version of the anesthetic bupivacaine with the anti-inflammatory meloxicam, produced a statistically significant 36.6 percent reduction in pain versus placebo through 96 hours following abdominoplasty.

Statistically significant reductions in pain were reported between 24 and 48 hours, 48 to 72 hours, and 72 to 96 hours compared with placebo after a single administration of HTX-011, the company said.

HTX-011 also led to statistically significant reductions in use of opioid medication, which could make it an important alternative if approved. Postsurgical use of opioids can cause severe constipation and lead to future abuse of the highly addictive pain drugs.

Following discussions with U.S. health regulators, Heron said it expects to begin larger Phase III studies this year with an eye toward seeking approval in 2018.

Heron said its combination pain therapy could be used following a wide range of surgical procedures involving small to very large incisions, such as with abdominoplasty. The drug, which is applied directly to the incision site, has previously been tested in bunionectomy and hernia repair.

Heron shares rose to $15 in extended trading from a Nasdaq close at $13.80.

© Copyright 2013-2019 GI Health Foundation. All rights reserved.
This site is maintained as an educational resource for US healthcare providers only. Use of this website is governed by the GIHF terms of use and privacy statement.