Heron Therapeutics Announces Filing of a Supplemental New Drug Application for Significant Expansion of ZYNRELEF® Indication Statement Based on Successful Outcome of FDA Type C Meeting

SAN DIEGO: SAN DIEGO, Oct. 4, 2021 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced submission of a supplemental New Drug Application (NDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution for an expanded indication. ZYNRELEF is currently indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. At a recent Type C meeting with the U.S. Food and Drug Administration (FDA), Heron gained agreement on the content of the supplement for expansion of the ZYNRELEF indication statement to include foot and ankle, small–to–medium open abdominal, and lower extremity total joint arthroplasty surgical procedures without the need for additional clinical studies. This submission is based on the consistent…
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