Milestone receives FDA approval for CARDAMYST (etripamil) nasal spray for PSVT

Milestone Pharmaceuticals Inc.

FDA approved CARDAMYST (etripamil) on Dec 12, 2025 for self-administration in adults with PSVT; first new treatment in 30+ years.
Phase 3 RAPID: 64% converted to sinus rhythm within 30 min vs 31% placebo (HR=2.62, p<0.001); median time 17 min vs 54 min.
Product expected in retail pharmacies Q1 2026; company well-capitalized for launch with existing capital and royalty financing.
FDA approval enables AFib-RVR development under sNDA pathway; Phase 3 program planned.

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