Milestone’s CARDAMYST Approval Delivers First Self-Administered PSVT Solution in Over 30 Years
First FDA-Approved At-Home Treatment Targets Two Million Americans With PSVT
Milestone Pharmaceuticals has received FDA approval for CARDAMYST™ (etripamil), introducing the first and only self-administered nasal spray for paroxysmal supraventricular tachycardia (PSVT) in adults. This marks the first time in more than three decades that a new treatment for PSVT—a condition impacting over two million Americans—will be accessible for patients to manage sudden, rapid heart rhythms outside emergency settings.
Clinical Data Highlights: Rapid Symptom Resolution and Strong Efficacy
CARDAMYST's approval is underpinned by results from robust clinical trials, including the Phase 3 RAPID trial. In the pivotal study, patients using CARDAMYST were two times more likely to return to normal sinus rhythm compared to placebo and did so over three times faster. Specifically, 64% of CARDAMYST users converted from PSVT to sinus rhythm within 30 minutes, versus 31% on placebo. At one hour, the rate improved to 73% for CARDAMYST. The median time to conversion for CARDAMYST was just 17 minutes—substantially quicker than the 54-minute median observed with placebo.
| Trial Metric | CARDAMYST | Placebo |
|---|---|---|
| Conversion Rate (30 min) | 64% | 31% |
| Conversion Rate (1 hr) | 73% | -- |
| Median Time to Conversion | 17 min | 54 min |
Safety Profile Remains Favorable
The clinical safety database spans over 1,800 participants and 2,000 episodes. Most side effects were mild or moderate and transient, such as nasal discomfort, congestion, runny nose, throat irritation, and nosebleeds. Discontinuation due to side effects occurred in less than 2% of cases. A consistent safety and efficacy profile was observed even among participants already on other heart medications like beta blockers or calcium channel blockers.
Addressing Unmet Needs: Empowering Patients and Reducing Healthcare Burdens
Until CARDAMYST, treatment for PSVT often involved IV drugs in a hospital setting—posing both inconvenience and anxiety for patients, as well as added costs for healthcare systems. CARDAMYST gives adults a tool to manage symptoms rapidly and regain control of their lives, reducing unnecessary emergency visits and potentially avoiding invasive procedures.
Commercial Outlook and Capital Strength
Milestone is well-positioned to support the CARDAMYST rollout, reporting $82.6 million in cash and investments as of September 30, 2025. The company anticipates an additional $75 million via a royalty purchase agreement, subject to customary closing conditions. CARDAMYST is expected to reach pharmacies in the first quarter of 2026.
| Financials (as of Sept 30, 2025) | Amount (USD) |
|---|---|
| Cash, Equivalents & Short-term Investments | $82.60 million |
| Expected Royalty Payment Post-Approval | $75.00 million |
Pipeline Momentum: Expanding Into AFib-RVR
Building on CARDAMYST’s PSVT approval, Milestone plans to advance etripamil’s application to atrial fibrillation with rapid ventricular rate (AFib-RVR), a condition affecting millions more. A pivotal Phase 3 program is underway, with a supplemental regulatory submission planned for this broader population.
Key Takeaway: New Era for Arrhythmia Patients
CARDAMYST’s approval signals a shift for adults with PSVT—delivering an at-home, rapid-acting solution and reshaping standard of care. As Milestone drives toward commercial launch and expanded research in related arrhythmias, investors and clinicians will be watching closely for the product’s real-world adoption and long-term impact on patient care and company growth.
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