Nasal Spray for PSVT gets FDA approval

Posted by psyche @psyche, Dec 13, 2025

I believe the FDA JUST approved the first ever nasal spray treatment Cardamyst=Etripamil for self-administration to abort PSVT episodes. This has been in the works for a long time. There is going to be an audio call for people who are interested on 12/15/25. Milestone is the drug company. If you google this, you can find the link and get more specific information.

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Yes — your understanding is correct. The FDA just approved CARDAMYST™ (etripamil), a nasal spray for self-administration to abort acute PSVT (paroxysmal supraventricular tachycardia) episodes, which is the first such treatment ever cleared for this use. This is a major milestone for PSVT patients and for Milestone Pharmaceuticals (Nasdaq: MIST).

On December 12, 2025, the FDA approved CARDAMYST™ (etripamil) nasal spray for adults with PSVT, making it the first self-administered treatment for this condition that patients can use outside of a hospital or clinic.

The product is a rapid-acting calcium channel blocker designed to rapidly convert episodes of PSVT to normal sinus rhythm when taken at the onset of symptoms.

This approval gives over 2 million Americans with PSVT a convenient way to self-manage acute episodes, potentially reducing emergency room visits.

CARDAMYST is expected to be available in retail pharmacies in the first quarter of 2026.

Clinical Data:

The approval is based on robust clinical data, including a Phase 3 RAPID trial showing significantly faster conversion to normal rhythm compared with placebo.

Upcoming Conference Call:

Milestone is hosting an **audio call and webcast on **Monday, December 15, 2025, at 8:00 a.m. ET to discuss this FDA approval and company plans. You can usually find the link to the webcast, dial-in details, and slides on the Milestone Pharmaceuticals “News & Events” page of their investor website ahead of time.

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I also believe that it, or a similar drug, is being trialed for paroxysmal AF and could be available soon.

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Milestone Pharmaceuticals Announces U.S. Availability of CARDAMYST™ (etripamil) Nasal Spray, the First and Only FDA-Approved Self-Administered Treatment for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)
January 26, 2026
PDF Version
CARDAMYST is now conveniently available to patients through retail pharmacies
National sales force hired with promotional launch in mid-February
Expected $25 copay cap for eligible commercially insured patients
Launch supported by comprehensive patient assistance program offering benefits verification and reimbursement support
CARDAMYST™ (etripamil) nasal spray
CARDAMYST™ (etripamil) nasal spray, the first and only FDA-approved self-administered treatment for adults with paroxysmal supraventricular tachycardia (PSVT), is now available through U.S. retail pharmacies. For more information, please visit CARDAMYST.com.

MONTREAL and CHARLOTTE, N.C., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that CARDAMYST™ (etripamil) nasal spray, its first commercial product, is now available through U.S. retail pharmacies. CARDAMYST is a prescription medication indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Implementation of a rapid commercialization plan is underway with a national sales force to be deployed in mid-February 2026.

CARDAMYST will launch with the support of a patient assistance platform as Milestone continues to negotiate with insurers for formulary placement and coverage. The program provides benefits verification, reimbursement support, and copay assistance for most patients with commercial insurance that covers CARDAMYST, helping to reduce financial and administrative barriers to treatment. For eligible commercially insured patients, copays are expected to be capped at $25, reinforcing Milestone’s commitment to making CARDAMYST affordable for patients who need it.

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