Heron's pain drug nails PhIII, prepping the company for NDA later this year
San Diego’s Heron Therapeutics $HRTX is on a roll, today trumpeting good news from its Phase III trial in post-operative pain. The promising data will back the drugmaker’s bid for FDA approval of the drug later this year. If approved, it would be the second FDA OK for Heron in a matter of months.
The news is sending Heron’s stock price soaring, up nearly 26% since the announcement.
The company’s pain drug is a long-acting local anesthetic made up of bupivacaine and meloxicam, which Heron calls HTX-011. The drug was tested in two Phase III studies that measured post-surgery pain and opioid use after bunionectomy (bunion removal) and hernia repair. HTX-011 achieved all its primary and secondary endpoints in both trials, according to Heron.
“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,” said Heron’s CEO Barry Quart in a statement.
In the bunion trial, patients taking HTX-011 saw a 27% drop in pain intensity compared to the placebo group, and an 18% drop compared to the group taking bupivacaine, the current standard-of-care. Patients on the drug also used 37% fewer opioids than placebo patients and 25% fewer than bupivacaine patients.
In the hernia trial, patients on Heron’s drug saw a 23% reduction in pain compared to placebo, and a 21% drop compared to bupivacaine. Patient on HTX-011 took 38% fewer opioids post-surgery than the placebo group, and 25% less than the bupivacaine group.
In a note to investors last month, analysts at Jefferies suggested the pivotal readout for HTX-011 would be a “significant catalyst” for Heron. The company plans to file an NDA for the program later this year.
The good news for the company follows a regulatory win just months ago, when Heron scored FDA approval of Cinvanti to prevent nausea and vomiting for patients on chemo. It was the second anti-nausea drug in Heron’s product portfolio, with Sustol approved last August for the same indication.
Shares at Heron have steadily climbed 52% over the past 12 months. As of press time, the stock had climbed to $27.00 per share, up from yesterday’s close of $21.50.