Heron Therapeutics’ Aponvie (HTX-019) Receives the US FDA’s Approval for the Prevention of Postoperative Nausea and Vomiting
Shots:
- The US FDA has approved Aponvie injectable emulsion for IV use to prevent postoperative nausea & vomiting in adults
- The approval was based on the 2 clinical studies evaluating aprepitant vs IV ondansetron in patients with PONV. The results showed that aprepitant was more effective in preventing vomiting with ~50% fewer patients vomiting in the first 24 & 48hrs., after open abdominal surgery
- The P-I trial showed that 32mg of aprepitant as a 30-second IV injection was bioequivalent to aprepitant (40mg), was well tolerated with a comparable safety profile. The product is ready-to-use, easy to administer, innovative IV formulation & was supplied in a single-dose vial containing 32mg of aprepitant
Ref: PRNewswire | Image: Heron Therapeutics
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