Heron Therapeutics has two drugs on the market to prevent the nausea and vomiting associated with chemotherapy. Now, it has one to prevent the sickness that often comes after surgery.
Friday, the FDA approved Aponvie, which becomes the first intravenous P/neurokinin-1 (NK) receptor antagonist available for postoperative nausea and vomiting (PONV) in adults.
Delivered in a single 30-second IV injection, Aponvie is the same drug as Merck’s Emend, which is now widely available as a generic. The difference is its IV formulation as opposed to Emend, which is taken in pill form.
The advantage of Aponvie—which is a 32-mg dose—is the combination of its rapid effect and staying power. Within five minutes of administration, it achieves 97% receptor occupancy in the brain and it maintains its plasma concentrations for at least 48 hours.
Aponvie won FDA approval based on data from two trials comparing it to the current standard of care, GSK’s oral Zofran. Treatment with Aponvie resulted in roughly 50% fewer patients vomiting in the first 24 and 48 hours compared with Zofran, while maintaining the same safety profile.
Like Emend, Zofran has a variety of generic alternatives. The GSK drug won FDA approval in 1991.
For Heron, the Aponvie green light comes after the company won a highly anticipated FDA approval for opioid alternative Zynrelef, used to manage postoperative pain. The dual-acting local anesthetic has been tabbed by analysts as a potential blockbuster.
“Our acute care portfolio now addresses the two most common concerns of patients and clinicians after surgery, postoperative pain and postoperative nausea and vomiting,” Heron CEO Barry Quart said in a release.
Quart added that there are 36 million procedures performed in the U.S. each year in which patients are at a moderate to high risk for PONV. Roughly 80% of high-risk patients experience PONV, Heron said.
Heron’s drugs to treat chemotherapy-induced nausea and vomiting are Cinvanti, which won FDA approval in 2017 and generated sales of $73.5 million last year, and Sustol, which was approved in 2016 and pulled in $9.9 million in 2021.