Milestone Pharmaceuticals Advances Etripamil Nasal Spray Approval Process in Europe
On January 6, 2026, Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company specializing in cardiovascular medicines, announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for its promising product, etripamil nasal spray. This innovative treatment is aimed at providing patients with paroxysmal supraventricular tachycardia (PSVT) a safe and effective self-administered option outside of healthcare settings. A decision regarding the approval is anticipated by the first quarter of 2027.
Significance of the Etripamil Nasal Spray
Etripamil, known as TACHYMIST™ in Europe, represents a novel approach in the management of PSVT. It is designed as a rapid-response treatment option, using a self-administered nasal spray formulation. As reported by Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, this application builds upon the extensive clinical data that supported the drug's approval by the U.S. Food and Drug Administration (FDA).
- The MAA is based on robust clinical trial data involving over 1,800 participants and more than 2,000 PSVT episodes.
- The Phase 3 RAPID trial was published in The Lancet, demonstrating significant efficacy.
- A potential market of approximately two million individuals suffering from PSVT in Europe.
Phase 3 Trial Results Highlight Efficacy
The MAA was substantiated by the results from the pivotal Phase 3 RAPID trial. This global randomized controlled trial showed that patients using etripamil were two times more likely to convert symptomatic PSVT to a normal sinus rhythm than those receiving a placebo. Key outcomes from the trial included:
- 64% of participants self-administering etripamil converted from PSVT to sinus rhythm within 30 minutes.
- Only 31% of participants on placebo achieved the same result (HR=2.62; p<0.001).
- By one hour post-administration, 73% of those using etripamil had converted to normal rhythm.
Importantly, etripamil demonstrated a swift median conversion time of 17 minutes, significantly faster than the 54 minutes for placebo-treated participants.
Safety Profile and Tolerability
The safety profile of etripamil remained consistent across diverse participant subgroups, including those on concurrent beta blockers and calcium channel blockers. Adverse events were predominantly mild to moderate, with common effects including:
- Nasal discomfort
- Nasal congestion
- Throat irritation
- Rhinorrhea
- Epistaxis
Notably, less than 2% of trial participants discontinued therapy due to side effects, emphasizing etripamil's tolerability.
The Need for Effective PSVT Treatments
PSVT affects roughly two million individuals in both the United States and Europe, characterized by episodes of rapid heartbeats that can exceed 150 to 200 beats per minute. Such episodes can lead to severe symptoms, including palpitations, shortness of breath, and anxiety. Currently, many patients are left with limited options, often resorting to emergency care or invasive procedures. Etripamil seeks to fill this treatment gap, offering a self-managed option that may empower patients.
About Etripamil and Milestone Pharmaceuticals
Etripamil is also marketed under the brand name CARDAMYST™ in the United States. It is not only approved for acute symptomatic episodes of PSVT but is also in development for other indications, including pediatric patients and acute atrial fibrillation treatment.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) remains committed to delivering innovative cardiovascular therapies to enhance patient care and improve quality of life.
Cautionary Note on Forward-Looking Statements:This article includes forward-looking statements regarding future events, including the potential approval of etripamil by the EMA, which involves risks and uncertainties that could cause actual results to differ significantly. Investors are encouraged to consider these factors when assessing the future performance of Milestone Pharmaceuticals.