Heron Therapeutics Inc. announced it has received FDA approval of Aponvie injectable emulsion, also known as HTX-019, for IV use for the prevention of postoperative nausea and vomiting in adults.
The first and only IV formulation of aprepitant for postoperative nausea and vomiting (PONV) prevention, Aponvie (aprepitant, Heron) is provided in a single-dose vial that delivers a 32 mg dose administered through a single 30-second IV injection, according to a company press release. The release noted IV aprepitant reaches drug levels associated with 97% or greater receptor occupancy in the brain within 5 minutes and maintains therapeutic plasma concentrations for at least 48 hours.
Results from two multicenter, randomized, double-blind clinical trials used for FDA approval showed oral aprepitant was more effective than IV ondansetron in preventing vomiting in the 48 hours following open abdominal surgery. The release also noted approximately 50% fewer patients vomited in the first 24 and 48 hours with aprepitant vs. ondansetron. IV aprepitant was well-tolerated and presented a safety profile comparable to oral aprepitant in clinical studies, according to the release.
“With the approval of Aponvie, our acute care portfolio now addresses the two most common concerns of patients and clinicians after surgery, postoperative pain and postoperative nausea and vomiting. This marks an important milestone for our expanding acute care portfolio and is a testament to our ongoing commitment to developing innovative solutions to help improve the overall patient experience after surgery,” Barry Quart, PharmD, chair and CEO of Heron, said in the release. “With approximately 36 million procedures in the U.S. each year in patients with high to moderate risk for PONV, the approval of Aponvie provides an easy to use, highly effective option for these patients that fits seamlessly into our acute care franchise.”
Heron Therapeutics announces U.S. FDA approval of Aponvie (HTX-019) for the prevention of postoperative nausea and vomiting (PONV). Published Sept. 16, 2022. Accessed Sept. 21, 2022.