=Heron Pharmaceuticals (HRTX) : Its pain drug trumps a key rival

• Heron Pharmaceuticals (HRTX)'s post-surgical pain drug outperformed a rival from Pacira Pharmaceuticals (PCRX) in a pair of head-to-head tests.

Heron Therapeutics announces 'positive' topline results from its completed Phase 3 studies of the investigational agent HTX-011 in subjects undergoing bunionectomy and hernia repair 

HTX-011 achieved all primary and key secondary endpoints in both Phase 3 trials, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72 hours following surgery.

• Co states, "We look forward to submitting a New Drug Application for HTX-011 to the U.S. 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."

The trial pitted Heron's drug HTX-011 and Pacira's already-approved Exparel in patients who had either had a bunion removed or a hernia repaired. In both cases, HTX-011 was superior to a placebo and Exparel, Heron said in a news release.

Needham analyst Serge Belanger says the data likely support a broad label for HTX-011 if approved. HTX-011 also cut down on the number of patients needing opioids to curb their pain.

"Heron believes the data supports an opioid-sparing label, which would be a significant game-changer," Belanger said in a note to clients. He raised his price target on Heron to 42 from 30, and kept his buy rating.

HTX-011 cut pain through 72 hours following surgery by 27% and 23%, respectively, vs. a placebo in bunion and hernia patients. On the same measure vs. Exparel, HTX-011 reduced pain by 18% and 21%, respectively.

Among bunion patients, 29% required no opioids for 72 hours following surgery vs. 2% and 11% of patients on a placebo and Exparel, respectively. Of hernia patients, 51% didn't need opioids for pain management vs. 22% and 40% of placebo- and Exparel-receiving patients.

"Overall, the Phase 3 data confirm prior results seen in three Phase 2 trials where HTX-011 was superior to placebo and (Exparel) on both pain relief and opioid consumption," Belanger said.

In late 2018, Heron plans to report data from two Phase 2 trials of HTX-011 in pain relief for patients after knee replacement surgery and following breast augmentation, he said. The data are expected to be part of Heron's application for approval of HTX-011.

"There are an estimated 300 million surgical procedures in the U.S. on an annual basis that require postoperative pain management," Belanger said.

HTX-011 is poised to be a "major player" in that industry. Exparel currently holds about 3% of the market and generates around $300 million in annual sales, he said.