FDA
Cardamyst OK’d for self-treatment of PSVT
Brand name: Cardamyst
Generic name: etripamil
Manufacturer: Milestone Pharmaceuticals
Approval date: December 12, 2025
FDA has approved Cardamyst (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
Etripamil is an L-type calcium influx inhibitor that exerts its pharmacologic effect by modulating the influx of ionic calcium across the cell membrane of the AV nodal cells as well as arterial smooth muscles and contractile myocardial cells.
Efficacy
Approval was based on data from the phase 3 RAPID trial (NCT03464019), which achieved its primary endpoint with 64% of those who self-administered Cardamyst converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes vs. 31% on placebo (hazard ratio [HR], 2.62; p<0.001). The median time to conversion was 17 minutes (95% confidence interval [CI], 13.4-26.5) for those treated with Cardamyst vs. 54 minutes (95% CI, 38.7-87.3) for those treated with placebo.
Safety
The most common adverse reactions (≥5%) were nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis.
Sources:
Cardamyst (etripamil) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218571s000lbl.pdf Revised December 2025. Accessed December 19, 2025.
Milestone receives FDA approval of Cardamyst™ (etripamil) as first and only self-administered nasal spray for adults with paroxysmal supraventricular tachycardia (PSVT). [News release]. 2025. https://investors.milestonepharma.com/news-releases/news-release-details/milestone-receives-fda-approval-cardamysttm-etripamil-first-and