In April, the U.S. Food and Drug Administration kicked back an application from Heron Therapeutics asking for approval of its experimental pain medicine.
Jump to Oct. 28, and the biotech said the U.S. Food and Drug Administration accepted its resubmitted application. With that, the FDA will give the thumbs up or down by March.
Last spring the FDA issued to Heron what’s called a complete response letter requesting additional chemistry manufacturing and controls information. The company emphasized that the agency didn’t identify any clinical safety or efficacy issues for HTX-011, a postoperative pain aesthetic pitched as an alternative to opioids.
Nonetheless, a stock sell-off ensued. On Oct. 28 with the resubmission acceptance, Heron’s stock increased 5.7% to close at $20.97.
HTX-011 Back On Track
Analyst Josh Schimmer with Evercore ISI said he thought fear over the complete response letter was overblown. With HTX-011 back on track, he said it has “blockbuster potential.”
Outside the U.S., Schimmer expects the drug to be approved in the European Union in mid-2020, and Heron is expected to file for approval in Canada in the next few months.
In August, the company reported that HTX-011 reduced pain and the use of opioids after hernia surgery in a late-stage clinical trial, or phase 3. It performed better on those two fronts than a placebo and the anesthetic bupivacaine, while being safe, the company said.
Earlier, HTX-011 generated positive results in a phase 3 clinical trial in bunionectomy. It was the same story for phase 2b trials in total knee arthroplasty and breast augmentation, according to the company.
HTX-011 is a long-acting, fixed-dose combination of the anesthetic bupivacaine with anti-inflammatory drug meloxicam. Heron says its drug comes at a critical time.
Some 80% of patients undergoing surgery are prescribed opioids to help manage post-operative pain, opening the door to addiction, as well as leftover pills accessible to others in the home.
“There remains a significant need for a new, non-opioid postoperative pain management option that can manage pain through the 72 hours after surgery, when pain is most intense,” said in a statement Roy Soto, director of the education and anesthesiology residency program at Beaumont Health System. “The surgical setting is a key place we can have a dramatic impact on the opioid crisis, by reducing the amount of opioids used after surgery and, ultimately, the number of unused pills in our homes and communities.”