FDA Approves Etripamil as First At-Home Option for Paroxysmal Supraventricular Tachycardia

The FDA approved etripamil (Cardamyst) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The approval is the first for a rapid-acting treatment option that is self-administered outside of an emergency department or other health care setting.¹

“Some people with PSVT have endured years of anxiety, fearing their next episode and the stress and disruption of emergency department visits,” James Ip, MD, FACC, FHRS, an etripamil investigator, said in a news release¹. “Cardamyst will give many of them the ability to administer a medication themselves that can quickly stop their PSVT episode and potentially avoid a hospital trip or a call to emergency services.”

The approval was based on clinical trial data from over 1800 patients and more than 2000 episodes of PSVT, including the phase 3 RAPID (NCT03464019) trial.¹ The trial was a 3-part, multicenter, randomized trial that evaluated the efficacy and safety of etripamil nasal spray for PSVT in an at-home setting. The episodes were documented by an ambulatory cardiac monitoring system that was placed on the chest when symptoms began and recorded at least 5 hours of continuous electrocardiogram. In part 1, individuals received the study drug or the placebo at a 2:1 ratio to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. In part 2, the patients who did not receive the study drug received a test dose of the drug followed by a second dose 10 minutes later. Then, patients received randomized treatment 1:1 with the study drug or placebo. Part 3 had the same design as part 2. The main outcome of the study was time to conversion of an episode of PSVT to sinus rhythm after study drug administration.²

In the study, investigators reported that patients receiving etripamil were 2 times more likely to convert symptomatic PSVT to sinus rhythm, which happened 3 times faster than with the placebo. Conversion rates by 30 minutes were 64% for etripamil and 31% for the placebo. Median time to conversion was 17 minutes and 53 minutes, respectively.^1,3

As for safety, 50% of patients receiving etripamil and 11% of patients receiving the placebo had treatment-emergent adverse events (TEAEs). The most common were located at the administration site and were moderate or mild in nature. TEAEs occurring in at least 5% of partitions included nasal discomfort at 23%, nasal congestion at 13%, and rhinorrhea at 9%, and no serious adverse events or deaths were reported in relation to etripamil.³ Less than 2% of participants discontinued therapy due to TEAEs.¹

“Our goal is that Cardamyst will become a trusted and essential solution for health care providers and their patients,” Lorenz Muller, chief commercial officer of Milestone, said in the news release.¹ “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.”

READ MORE: Cardiology Resource Center

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REFERENCES

1. Milestone receives FDA approval of Cardamyst (etripamil) as first and only self-administered nasal spray for adults with paroxysmal supraventricular tachycardia. Milestone. News release. December 12, 2025. Accessed December 15, 2025. https://www.globenewswire.com/news-release/2025/12/13/3204944/0/en/Milestone-Receives-FDA-Approval-of-CARDAMYST-etripamil-as-First-and-Only-Self-Administered-Nasal-Spray-for-Adults-with-Paroxysmal-Supraventricular-Tachycardia-PSVT.html

2. Efficacy and safety of etripamil for the termination of spontaneous paroxysmal supraventricular tachycardia (PSVT). (NODE-301). ClinicalTrials.gov identification: NCT03464019. Updated July 12, 2024. Accessed December 15, 2025. https://clinicaltrials.gov/study/NCT03464019

3. Stambler BS, Camm AJ, Alings M, et al. Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial. Lancet. 2023;402(10396):118-128. doi:10.1016/S0140-6736(23)00776-6