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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
- FDA agreed to the immediate filing of supplemental NDA to significantly expand the ZYNRELEF indication statement based on previously submitted data with no
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- FDA agreed to the immediate filing of supplemental NDA to significantly expand the ZYNRELEF indication statement based on previously submitted data with no new clinical studies -\n - FDA also agreed on the required studies to support a broad soft tissue and orthopedic indication statement with a second supplemental NDA, planned for 2022 -\n\n\nSAN 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 safety, efficacy and pharmacokinetic data from previously completed clinical trials. \nAlignment was also reached with the FDA on the data needed to support a future supplemental NDA to further expand the ZYNRELEF indication statement to broadly include soft tissue and orthopedic surgical procedures with pharmacodynamic, pharmacokinetic and safety data from a limited number of additional procedures. The studies in these additional surgeries are already in progress with the plan to submit the next supplement in the second half of 2022. \n\"Our Type C meeting with the FDA was very positive, with alignment on next steps for the submission of two sequential supplemental NDAs designed to expand the ZYNRELEF indication statement in a stepwise fashion. The first label expansion is designed to significantly increase the annual number of indicated surgical procedures and the second label expansion is anticipated to broadly cover 14 million targeted surgical procedure...