FDA Approves First Self-Administered Heart Arrhythmia Nasal Spray
- Dec 15
- 2 min read
Milestone Pharmaceuticals has achieved its first-ever FDA approval in its 22-year history with the green light for Cardamyst (etripamil), a fast-acting nasal spray designed to treat a debilitating heart condition. The U.S. regulator signed off on Cardamyst to quell symptomatic episodes of Paroxysmal Supraventricular Tachycardia (PSVT), a type of abnormal heart rhythm that causes a rapid heartbeat that starts and stops abruptly.
Crucially, Cardamyst is a calcium channel blocker that becomes the first self-administered treatment patients can use to manage their PSVT symptoms outside of a clinical setting. CEO Joe Oliveto highlighted that the nasal spray offers a convenient alternative to an emergency room visit, which is currently the common solution where patients receive an intravenous dose of a drug. Patients have sometimes described the IV treatment as "like a near death experience," making the prospect of self-management highly desirable. PSVT attacks, which can lead to heart rates up to 230 beats per minute, are sporadic and unpredictable, leading 70% of patients to report anxiety even when not experiencing an event. Cardamyst offers these patients "insurance in my pocket" and peace of mind.
Clinical data supporting the approval showed that participants using Cardamyst were twice as likely to convert symptomatic PSVT to normal sinus rhythm and did so more than three times faster than those on a placebo. The drug is delivered via one spray in each nostril, with the option for a second dose after 10 minutes if there is no response, a strategy that significantly boosted efficacy in trials.
The approval opens up an addressable market of more than two million Americans suffering from PSVT. Cardamyst is expected to be available for purchase at retail pharmacies in the first quarter of 2026 (Q1). The company has priced the prescription at $1,649. Milestone is now transitioning from a development company into a commercial one, with plans to quickly pursue label expansion for atrial fibrillation with rapid ventricular response (AFib-RVR), a condition affecting 10 to 12 million U.S. patients.
Following the news, shares of Milestone Pharmaceuticals (MIST) soared, rising nearly 32% in Monday’s pre-market trading. Retail sentiment trended in the "extremely bullish" territory, dismissing concerns of a "sell the news" event. Analysts have subsequently raised price targets, noting that current share levels may underappreciate the commercial potential of Cardamyst.
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Keywords: self-administered heart arrhythmia nasal spray
self-administered heart arrhythmia nasal spray
