FDA Approves Heron Therapeutics' Post-Op Nausea Treatment

The FDA approved Heron Therapeutics Inc's 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.
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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.