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Heron Therapeutics Announces U.S. FDA Approval of APONVIE™ (HTX-019) for the Prevention of Postoperative Nausea and Vomiting (PONV)
- APONVIE is the first and only intravenous (IV) formulation of a substance P/neurokinin-1 (NK1) receptor antagonist indicatedfor PONV - - Delivered via a
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- APONVIE is the first and only intravenous (IV) formulation of a substance P/neurokinin-1 (NK1) receptor antagonist indicatedfor PONV -\n- Delivered via a single 30-second IV injection, APONVIE has demonstrated rapid achievement of therapeutic drug levels ideally suited for the surgical setting -\nSAN DIEGO, Sept. 16, 2022 /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 that the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.\nAPONVIE is the first and only IV formulation of aprepitant for PONV prevention. Administered via a single 30-second IV injection, APONVIE reaches drug levels associated with ≥97% receptor occupancy in the brain within five minutes and maintains therapeutic plasma concentrations for at least 48 hours. APONVIE is provided in a single-dose vial that delivers the full 32 mg dose approved for PONV. This ready-to-use, easy to administer, innovative IV formulation ensures rapid and consistent exposure in patients undergoing surgery.\nAn important component of the FDA approval of APONVIE were results from two multicenter, randomized, double-blind clinical studies comparing oral aprepitant to current standard of care, IV ondansetron, for the prevention of PONV in patients during the 48 hours following open abdominal surgery demonstrating that aprepitant was more effective than ondansetron in preventing vomiting. Treatment with aprepitant resulted in approximately 50% fewer patients vomiting in the first 24 and 48 hours compared to ondansetron. In clinical studies, APONVIE was well-tolerated and presented a safety profile comparable to oral aprepitant.\nIn a 2020 Cochrane meta-analysis, aprepitant was ranked as the most effective drug approved for PONV prophylaxis, being the most effective for the prevention of vomiting in the first 24 hours post-surgery and the drug with the fewest adverse events.\n\"With the approval of APONVIE our acute care portfolio now addresses the two most common concerns of patients and clinicians after surgery, postoperative pain and postoperative...