FDA Approves Aprepitant for Prevention of Postoperative Nausea, Vomiting

The Food and Drug Administration (FDA) has approved Aponvie^™ (aprepitant) for the prevention of postoperative nausea and vomiting (PONV) in adults.

Aponvie is an intravenous (IV) injectable emulsion formulation designed to directly deliver aprepitant, a substance P/neurokinin-1 (NK₁) receptor antagonist, as a 30-second IV injection. Aponvie is identical to the FDA-approved Cinvanti injectable emulsion formulation, which is indicated for chemotherapy-induced nausea and vomiting. 

The treatment is intended to provide convenient, rapid exposure compared with the oral aprepitant formulation, which is administered 1 to 3 hours prior to anesthesia. A single 30-second IV injection of Aponvie reaches drug levels associated with at least 97% receptor occupancy in the brain within 5 minutes and maintains therapeutic plasma concentrations for at least 48 hours.

The approval is supported by data from 2 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 after open abdominal surgery. Findings showed that treatment with aprepitant was more effective in preventing vomiting with approximately 50% fewer patients vomiting in the first 24 and 48 hours compared with ondansetron.

Additionally, the application included data from a phase 1 trial which demonstrated that 32mg of aprepitant as a 30-second IV injection was bioequivalent to oral aprepitant 40mg for the prevention of PONV. As for safety, Aponvie was well tolerated with a comparable safety profile to oral aprepitant. 

Aponvie is supplied in a single-dose vial containing 32mg of aprepitant.

Reference

Heron Therapeutics announces US FDA approval of Aponvie^™ (HTX-019) for the prevention of postoperative nausea and vomiting (PONV). News release. Heron Therapeutics, Inc. Accessed September 16, 2022. https://www.prnewswire.com/news-releases/heron-therapeutics-announces-us-fda-approval-of-aponvie-htx-019-for-the-prevention-of-postoperative-nausea-and-vomiting-ponv-301626450.html

This article originally appeared on MPR