FDA Approves CARDAMYST for PSVT Treatment

MONTREAL and CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc.  (Nasdaq: MIST) today announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. CARDAMYST is expected to be available in retail pharmacies in the first quarter of 2026.

Milestone Pharmaceuticals has reached a significant milestone with the FDA's approval of CARDAMYST (etripamil), which is the first and only self-administered nasal spray specifically designed for adults suffering from Paroxysmal Supraventricular Tachycardia (PSVT). This innovative therapeutic approach promises to enhance the management of this fast-acting heart condition, offering patients a rapid and effective self-treatment option.

PSVT is characterized by episodes of a rapid heartbeat that may not be associated with any underlying heart disease. These episodes can be quite distressing and lead to symptoms like palpitations, dizziness, or even fainting. Previous treatment modalities required patients to seek immediate medical attention or rely on oral medications that may not provide quick relief. With the introduction of CARDAMYST, adults have the opportunity to self-administer treatment as needed, thereby potentially improving their quality of life.

The approval from the FDA follows rigorous clinical trials that demonstrated CARDAMYST's safety and efficacy. During these trials, patients were monitored closely, and the results indicated that etripamil effectively restored normal heart rates in a significant number of participants experiencing PSVT episodes. The self-administered nasal spray format is intended for ease of use, making it accessible for patients when they need it most.

Milestone Pharmaceuticals expressed enthusiasm about the approval, emphasizing their commitment to innovation in cardiovascular care. The company aims to improve patient outcomes through groundbreaking treatments like CARDAMYST, which not only address immediate health challenges but also empower patients by providing them with control over their condition.

In addition to its innovative formulation, CARDAMYST has the potential to transform how patients with PSVT manage their condition on a daily basis. By allowing patients to handle their symptoms quickly at home, the nasal spray could reduce emergency room visits and hospitalizations associated with PSVT episodes. Overall, this approval represents a promising advancement in the treatment landscape for this heart condition.

As more information becomes available, Milestone Pharmaceuticals is expected to continue providing education and support for patients and healthcare providers regarding the use of CARDAMYST. Ongoing studies may also explore long-term outcomes associated with the use of this treatment in a broader patient population.