FDA approves significantly expanded indication for Zynrelef

The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Zynrelef (bupivacaine and meloxicam) extended-release solution to significantly expand the indication, which was submitted by US drugmaker Heron Therapeutics (Nasdaq: HRTX), whose shares were up 6.2% at $9.05 by mid-morning.

Zynrelef is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

Zynrelef became commercially available in the US on July 1, 2021, but with a narrow lablel. Net product sales for the three and nine months ended September 30 were $2.1 million, but the expanded indication is expected to lead to improved revenues.