Health Canada Grants Priority Review for Heron’s Non-Opioid Pain Treatment

Heron Therapeutics received a priority review from Health Canada for its non-opioid postoperative pain treatment HTX-011.

HTX-011 is a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. In phase 3 studies, it significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

Heron filed an NDA for the drug in September after receiving a complete response letter for its previous NDA in August. The FDA is expected to approve the drug in March 2020.