HTX-011 Receives Breakthrough Therapy Designation from FDA for Postoperative Pain Management

Heron Therapeutics announced that the US Food and Drug Administration (FDA) granted HTX-011 breakthrough therapy designed for postoperative pain management.

The designation was granted based on results of phase 2 studies and 2 recently completed phase 3 studies, which demonstrated that the treatment produced significant reductions in both pain intensity and the need for opioids through 72 hours post-surgery versus placebo and bupivacaine solution—the standard of care.

“We are pleased that HTX-011 has received breakthrough therapy designation from the FDA,” Barry Quart, PharmD, chief executive officer, Heron Therapeutics, said in a statement. “HTX-011 is the only long-acting local anesthetic to demonstrate significantly reduced postoperative pain and opioid use through 72 hours compared to bupivacaine solution, the standard-of-care local anesthetic postoperative pain management, in phase 3 studies. We look forward to working towards the submission of a new drug application (NDA) to the FDA for HTX-011 in the second half of 2018.”

HTX-011 is an investigational, long-acting, extended-release formulation of bupivacaine, compiled in a fixed-dose combination with the nonsteroidal anti-inflammatory drug meloxicam for management of postoperative pain. The formulation was designed to deliver pain relief while reducing the need for systemically administered pain medications like opioids.

It has been shown to reduce pain significantly better than placebo or bupivacaine alone in 5 diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation.

Previously granted fast track designation in the fourth quarter of 2017 and breakthrough therapy designation in the second quarter of 2018, Heron expects to submit an NDA for HTX-011 to the FDA in the second half of 2018.