Dive Brief:
- Shares in Heron Therapeutics soared by 35% Thursday on news the biotech's non-opioid pain drug HTX-011 hit its primary endpoints in two Phase 2b studies in total knee arthroplasty and breast augmentation.
- Heron plans to submit HTX-011, which combines the local anesthetic bupivacaine and the anti-inflammatory meloxicam, to the Food and Drug Administration later this year for potential approval as a treatment for postoperative pain.
- In patients undergoing knee arthroplasty, HTX-011 alone and in combination with ropivacaine significantly reduced pain intensity at rest versus placebo, and was about twice as effective as bupivacaine alone. Notably, the combination significantly reduced opioid use compared with placebo. HTX-011 also lowered pain intensity and opioid use in patients undergoing breast augmentation.
Dive Insight:
Post-operative pain can affect how patients recover. By allowing patients to move around, pain control reduces the risk of complications such as pneumonia and blood clots, and increases ability to exercise and take part in physiotherapy. Controlling pain and inflammation can also help wound healing and minimize the chance of developing chronic pain.
At the same time, the opioid epidemic across the U.S. is showing few signs of abating, highlighting the need for non-opioid treatments.
"The superior pain relief provided by HTX-011 compared to the current standard of care may provide a significant clinical benefit for patients and, as part of a multimodal pain management regimen, has the potential to significantly reduce the amount of opioid medication required for patients in the early postoperative recovery period," said Paul Lachiewicz, a consulting professor in orthopedic surgery at Duke University, in a statement issued by Heron.
In March this year, Heron reported similar success from use of HTX-011 following bunionectomy or hernia repair. On Thursday, the drug also secured a Breakthrough Therapy Designation from the Food and Drug Administration for postoperative pain management.
The designation was assigned based on Phase 2 and Phase 3 results that showed significant reductions in pain intensity and the need for opioids 72 hours post-surgery compared with standard-of-care (bupivacaine) or placebo.
Physicians polled by Cowen, an investment firm, in March generally thought HTX-011 could eventually see strong uptake in eligible surgical procedures, if approved. Cowen predicts the drug will launch in 2019.