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MAR 11 2026
APPROVED · 202 DAYS AGO

Milestone Pharmaceuticals — Cardamyst (etripamil) $MIST

for paroxysmal supraventricular tachycardia (PSVT) — on-demand nasal spray

NDA · Standard Review

FDA approved Cardamyst (etripamil) nasal spray on or near the March 11, 2026 PDUFA date. First patient-administered acute PSVT therapy. Sponsor Watch confirms commercial launch with Q1 2026 revenue (below initial analyst expectations); RESET-PSVT real-world evidence registry is in the works.

About

Paroxysmal supraventricular tachycardia (PSVT) is a heart rhythm disorder that causes sudden, brief episodes of racing heartbeat, often with palpitations, lightheadedness, sweating, shortness of breath, or chest pain. Cardamyst is a nasal spray form of etripamil that blocks calcium channels in heart muscle cells, calming the electrical signals that drive a fast heartbeat. Because PSVT episodes start abruptly, a spray people can use themselves may potentially stop the racing rhythm quickly without a trip to the hospital.

Pivotal trial

NCT04952610 Phase 3 completed NCT04952610

This Open Label Extension study will enable eligible patients with Paroxysmal Supraventricular Tachycardia (PSVT) who have previously participated in a Milestone Pharmaceuticals clinical trial of etripamil NS for PSVT, to access continued treatment with etripamil NS, Patients who experienced any significant safety issues during participation period in a previous clinical trial of etripamil NS, as per Investigator's assessment , are excluded. This study will be conducted by Investigators who p...

Source: ClinicalTrials.gov

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