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Nasal Spray for PSVT gets FDA approval
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.
I also believe that it, or a similar drug, is being trialed for paroxysmal AF and could be available soon.