Milestone Pharmaceuticals(US:MIST) Globenewswire·2026-01-06 13:00Core Viewpoint - Milestone Pharmaceuticals has announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for etripamil nasal spray, aimed at treating paroxysmal supraventricular tachycardia (PSVT) outside of healthcare settings, with a decision expected by Q1 2027 [1][7] Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular medicines, with its lead product being CARDAMYST™ (etripamil) nasal spray, which is FDA approved for PSVT treatment in adults [9] Product Details - Etripamil is a novel calcium channel blocker delivered via nasal spray, designed for self-administration by patients, potentially offering a rapid response to PSVT episodes [1][6] - The product is conditionally approved in Europe under the brand name TACHYMIST™ [1][8] Clinical Trial Insights - The MAA submission is supported by data from over 1,800 participants and more than 2,000 PSVT episodes, including results from the Phase 3 RAPID trial, which demonstrated that 64% of participants using etripamil converted to sinus rhythm within 30 minutes compared to 31% on placebo [3][4] - Etripamil users were found to convert symptomatic PSVT to sinus rhythm more than three times faster than those on placebo, with a median conversion time of 17 minutes for etripamil versus 54 minutes for placebo [3] Safety Profile - A consistent safety profile was observed across all subgroups, with the most common adverse events being mild-to-moderate and transient, such as nasal discomfort and congestion [4] - Less than 2% of trial participants discontinued therapy due to adverse events [4] Market Potential - Approximately two million people in Europe are diagnosed with PSVT, indicating a significant market opportunity for etripamil as a self-administered treatment option [2][5]