FDA approves new nasal spray for patients with abnormal heart rhythms
As the old saying goes: If at first you don’t succeed, try, try again.
Milestone Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for etripamil, a new nasal spray for adult patients with paroxysmal supraventricular tachycardia (PSVT). Back in March, the FDA rejected the company’s initial submission for approval due to specific concerns about potential nitrosamine impurities. Now, nearly nine months later, it seems that those concerns have been addressed.
Milestone Pharmaceuticals will be selling etripamil under the brand name Cardamyst. It is expected to hit the U.S. market in early 2026.
“Our goal is that Cardamyst will become a trusted and essential solution for healthcare providers and their patients,” Lorenz Muller, chief commercial officer of Milestone Pharmaceuticals, said in a statement. “Our team is focused on making Cardamyst available to adults with PSVT as quickly as possible, including actively working to secure insurance coverage and begin the distribution of the product through retail pharmacies.”
“Adults with SVT have been waiting a long time for the day when they can confidently self-administer Cardamyst to treat their supraventricular tachycardia episodes,” added Annette Greene, a clinical trial participant and administrator of the popular Supraventricular Tachycardia Group on Facebook. “It is very exciting that the day has become a reality.”
FDA’s approval of etripamil based on positive trial data
The FDA’s approval was largely based on a randomized trial of nearly 200 PSVT patients who self-administered etripamil or a placebo. The median times to conversion from PSVT to sinus rhythm were 17 minutes for etripamil and 53 minutes for the placebo. No significant adverse events were reported. The full analysis was published in The Lancet in July 2023.[1]
Milestone Pharmaceuticals is also exploring the drug’s safety and effectiveness as a treatment option for atrial fibrillation with rapid ventricular rate (AFib-RVR). Research is still ongoing, and the company hopes to secure an additional approval for adult patients with AFib-RVR from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.