What's Happening?
Milestone Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for CARDAMYST, a nasal spray designed to treat paroxysmal supraventricular tachycardia (PSVT) in adults.
This marks the first FDA-approved self-administered treatment for PSVT in over 30 years, offering a new option for more than two million Americans affected by this condition. CARDAMYST is a rapid-acting calcium channel blocker that can be used by patients to manage episodes of PSVT outside of healthcare settings, providing them with greater control over their condition. The approval is based on a comprehensive clinical trial program, including the Phase 3 RAPID trial, which demonstrated the efficacy of CARDAMYST in converting PSVT to sinus rhythm more effectively and quickly than a placebo. The nasal spray is expected to be available in retail pharmacies by the first quarter of 2026.
Why It's Important?
The approval of CARDAMYST represents a significant advancement in the treatment of PSVT, a condition characterized by sudden episodes of rapid heart rate that can cause severe symptoms and anxiety for patients. Traditionally, treatment options required intravenous administration in healthcare settings, leading to stress and high costs for patients and insurers. With CARDAMYST, patients can now manage their condition independently, potentially reducing the need for emergency department visits and associated healthcare costs. This development not only provides a new therapeutic option for patients but also reflects a broader trend towards patient empowerment and self-management in healthcare. The approval also positions Milestone Pharmaceuticals as a key player in the cardiovascular treatment market, with plans to expand the use of etripamil for other conditions such as atrial fibrillation with rapid ventricular rate (AFib-RVR).
What's Next?
Following the FDA approval, Milestone Pharmaceuticals is preparing to launch CARDAMYST in the U.S. market, focusing on securing insurance coverage and distribution through retail pharmacies. The company is also planning to initiate a Phase 3 program for etripamil in treating AFib-RVR, leveraging the data from the successful PSVT trials. This expansion could further increase the market potential for etripamil, addressing a significant unmet need in the treatment of arrhythmias. Milestone is well-capitalized to support these initiatives, with existing capital and a royalty financing agreement in place. The company will host a conference call to discuss the approval and future plans, indicating a proactive approach to engaging with stakeholders and the medical community.
