FDA Approves IV Aponvie for Postoperative Nausea

The FDA has approved Heron Therapeutics’ Aponvie (aprepitant) injectable emulsion for the prevention of postoperative nausea and vomiting (PONV) in adults. Aponvie is the first IV formulation of aprepitant for postoperative nausea and vomiting prevention. It is provided as single-dose vial that delivers the full 32 mg dose and reaches drug levels within five minutes and maintains therapeutic plasma concentrations for at least 48 hours.

Aponvie is the same formulation as Heron’s approved Cinvanti, which is an injectable emulsion formulation for prevention of chemotherapy-induced nausea and vomiting.

“PONV is commonly experienced after surgery and may result in increased hospital stays, prolonged recovery time, and decreased patient satisfaction,” Ashraf Habib, MBBCh, chief, division of Women’s Anesthesia at Duke University Hospital. “Oral aprepitant has been used to prevent postoperative nausea and vomiting for more than 16 years and it is exciting to see that, with the approval of Aponvie, physicians can now offer patients a more convenient IV injection that delivers the same effective treatment, with a 48-hour duration of effect, in a rapid, consistent and reliable way, ensuring a better experience for patients postoperatively.”

The approval is based on data demonstrating the bioequivalence of Aponvie (formerly HTX-019) 32 mg as a 30-second IV injection to oral aprepitant 40 mg. Results also showed Aponvie was well-tolerated with a similar safety profile compared with oral aprepitant. Because it is administered as an IV injection, Aponvie provides convenient, rapid, consistent, and reliable exposure in all patients and overcomes the need to take the oral formulation 1 to 3 hours before anesthesia.

A new drug application (NDA) for the IV aprepitant (formerly HTX-019) was submitted in November 2021. There are about 39 million surgical procedures annually where patients are at risk for postoperative nausea and vomiting.