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MAR 11 2026
APPROVED · 84 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) causes sudden episodes of rapid heartbeats that can trigger palpitations, dizziness, and chest discomfort. Cardamyst (etripamil) is a nasal spray that blocks calcium channels in heart cells to slow electrical signals during an attack. By letting patients self-treat episodes at home, it may quickly restore normal rhythm without emergency care.

Pivotal trial

NCT05410860 Phase 3 completed NCT05410860

To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home setting; To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers. To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo

Source: ClinicalTrials.gov

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