Milestone Pharmaceuticals Inc. (MIST) announced that the European Medicines Agency has accepted for review the company's Marketing Authorization Application for Etripamil nasal spray, a self-administered therapy for paroxysmal supraventricular tachycardia.
Paroxysmal supraventricular tachycardia (PSVT) is a common arrhythmia affecting an estimated two million people in Europe, characterized by sudden episodes of rapid heartbeat that can exceed 150 to 200 beats per minute. These episodes often cause severe palpitations, chest discomfort, dizziness, and shortness of breath, frequently forcing patients to seek emergency care.
Etripamil, which carries the conditionally approved brand name TACHYMIST in Europe, is a fast-acting calcium channel blocker delivered via a nasal spray. Designed for patient self-administration, it aims to provide a rapid, reliable option to convert PSVT episodes to normal rhythm outside of a healthcare setting.
The EMA decision is expected by the first quarter of 2027. The application incorporates the global clinical data package that supported the U.S. FDA approval of Etripamil, marketed as CARDAMYST in the U.S. for acute PSVT episodes in adults.
The submission is backed by data from more than 1,800 participants and over 2,000 PSVT episodes, including results from the pivotal Phase 3 RAPID trial. In the study, 64% of patients self-administering Etripamil converted to sinus rhythm within 30 minutes, compared with 31% on placebo. Median time to conversion was 17 minutes for Etripamil versus 54 minutes for placebo.
Safety findings were consistent across subgroups, with most adverse events being mild, transient nasal-related symptoms.
If approved, TACHYMIST would become the first patient-administered therapy for PSVT in Europe offering an alternative to emergency department visits or invasive ablation procedures. Milestone noted that the therapy may give patients greater control over unpredictable episodes and reduce the burden on the healthcare systems.
Etripamil nasal spray was approved in the U.S. as recently as December 12, 2025. The product, which will be marketed under the brand name CARDAMYST, is expected to be available in retail pharmacies this quarter.
MIST has traded between $0.62 and $3.06 over the past year. The stock closed yesterday's trading at $2.05, up 1.49%.
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