The European Medicines Agency has accepted Milestone Pharmaceuticals’ marketing application for etripamil nasal spray (TACHYMIST™) for paroxysmal supraventricular tachycardia, supported by Phase 3 RAPID trial data.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Milestone Pharmaceuticals Inc. a clinical-stage biopharmaceutical company focused on innovative cardiovascular medicines, has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) seeking approval of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT).
Citing guidance from the European Medicines Agency, Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals, said the Marketing Authorization Application incorporates the same global clinical data package that supported U.S. FDA approval of etripamil for PSVT. He added that TACHYMIST has the potential to become the first approved patient self-administered therapy, representing a meaningful step forward in care for nearly two million people living with PSVT in Europe.
The EMA’s decision on the application is expected by the first quarter of 2027.
What Is Etripamil?
Etripamil is a novel calcium channel blocker formulated as a nasal spray for the rapid termination of paroxysmal supraventricular tachycardia episodes. Its intranasal delivery enables quick absorption and fast restoration of normal heart rhythm. In clinical studies, patients self-administered etripamil at the onset of an episode, significantly reducing the time to conversion to sinus rhythm compared with placebo.
If approved in Europe, etripamil, under the proposed brand name TACHYMIST™, could become the first home-based, patient self-administered option for managing acute PSVT without the need for immediate medical supervision.
Clinical Evidence
The European Marketing Authorization Application for etripamil nasal spray is supported by Milestone Pharmaceuticals’ late-stage global clinical development program, including the Phase 3 RAPID trial (NCT03464019). This randomized, double-blind, placebo-controlled study evaluated intranasal etripamil, administered by patients during symptomatic episodes of paroxysmal supraventricular tachycardia, in an out-of-hospital setting.
In the RAPID trial, 64% of patients receiving etripamil (n=99) achieved conversion from supraventricular tachycardia to normal sinus rhythm within 30 minutes, compared with 31% of patients receiving placebo (n=85). By one hour, conversion to sinus rhythm was observed in 73% of etripamil-treated patients.
Etripamil demonstrated a faster and more sustained response, with a median time to conversion of 17 minutes versus 54 minutes for placebo. Separation between treatment groups was observed early and maintained throughout the assessment period. The safety profile was consistent with prior clinical studies, with most adverse events reported as mild to moderate in severity and predominantly related to nasal administration.
Strategic Importance and Market Impact
The EMA’s acceptance of the MAA reflects momentum for Milestone on the global regulatory front. The company already secured FDA approval for its nasal spray formulation, branded as CARDAMYST™, for adults with PSVT in the United States in December 2025.
Secure approval in Europe would establish etripamil as a first-of-its-kind therapy in multiple major markets. With millions living with PSVT across Europe, the ability to self-administer a rapid-acting treatment could shift care away from emergency settings toward patient-centered management.
Additionally, Milestone continues to explore etripamil’s application in treating other arrhythmias, such as atrial fibrillation with rapid ventricular rate (AFib-RVR), potentially expanding the clinical utility of this nasal spray platform.
About PSVT
PSVT is a type of supraventricular arrhythmia characterized by sudden episodes of rapid heart rate originating above the heart’s ventricles. These episodes can cause palpitations, light headedness, shortness of breath, and anxiety. While not usually life-threatening, PSVT symptoms are disruptive and often lead patients to seek emergency care.
Reference
Milestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency, 06 January 2026, https://investors.milestonepharma.com/news-releases/news-release-details/milestone-pharmaceuticals-announces-acceptance-marketing
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT). (NODE-301), ClinicalTrials.gov ID NCT03464019, https://clinicaltrials.gov/study/NCT03464019
Stambler, Bruce SIp, James E et al., Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial, The Lancet, Volume 402, Issue 10396, 118 – 128, https://doi.org/10.1016/S0140-6736(23)00776-6