Heron drug for post-surgery pain succeeds in midstage trial

[January 05, 2017]  (Reuters) - Heron Therapeutics Inc on Wednesday said its experimental combination drug for post-operative pain led to significant reductions in pain intensity and the 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. But the gains were erased after the company issued a disappointing 2017 sales forecast for its drug for chemotherapy-induced nausea.

The pain 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, a cosmetic procedure commonly known as a tummy tuck.

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 the need for opioid medication, which could make it an important alternative if approved. Post-surgical 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 initially rose to $15 in extended trading from a Nasdaq close at $13.80. They fell to $12.45 after the company, in a securities filing, forecast 2017 Sustol sales of $15 million to $25 million. Wall Street was estimating about $50 million in sales for the nausea treatment.

(Reporting by Bill Berkrot; Editing by Leslie Adler)

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