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FDA Approves Heron Therapeutics' Post-Op Nausea Treatment

FDA Approves Heron Therapeutics' Post-Op Nausea Treatment

美国食品药品管理局批准Heron Therapeutics的术后恶心治疗
Benzinga Real-time News ·  2022/09/19 06:42
  • The FDA approved Heron Therapeutics Inc's (NASDAQ:HRTX) Aponvie (aprepitant) injectable emulsion for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.
  • Aponvie is the first and only IV formulation of aprepitant for PONV prevention.
  • Aponvie is provided in a single-dose vial that delivers the full 32 mg dose approved for PONV. The ready-to-use, easy-to-administer, innovative IV formulation ensures rapid and consistent exposure in surgery patients.
  • Related: Heron Shares Jump After Equity Financing, Q2 Earnings.
  • 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.
  • Clinical studies comparing oral aprepitant to the current standard of care, IV ondansetron, demonstrated that aprepitant was more effective.
  • 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.
  • In a 2020 Cochrane meta-analysis, aprepitant was ranked as the most effective drug approved for PONV prophylaxis, the most effective for preventing vomiting in the first 24 hours post-surgery, and the drug with the fewest adverse events.
  • Price Action: HRTX shares closed 4.11% lower at $4.67 on Friday.
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