NDA for Non-Opioid Combo Tx for Postoperative Pain Submitted to FDA

A New Drug Application (NDA) has been submitted for HTX-011 (Heron Therapeutics), a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the nonsteroidal anti-inflammatory drug meloxicam, for postoperative pain.

HTX-011 was previously granted Breakthrough and Fast Track designations by the Food and Drug Administration (FDA). The treatment is designed to deliver pain relief directly to the site of tissue injury, thereby potentially reducing the need for systemically administered pain medications.

The NDA includes results from 7 clinical studies involving 5 bony and soft tissue procedures that included ≥1000 patients. In the Phase 3 trials, HTX-011 was associated with superior, sustained postoperative pain relief for 72 hours. Moreover, a greater portion of patients were opioid-free in the HTX-011 group vs the placebo and bupivacaine solution group (current standard-of-care).

“The clinical results with HTX-011 suggest it may be one of the most promising new non-opioid analgesics for a wide range of surgical procedures,” said Harold S. Minkowitz, MD, associate professor and associate director of clinical research at the University of Texas MD Anderson Cancer Center.

For more information visit Herontx.com.