What's Happening?
The U.S. Food and Drug Administration (FDA) has approved etripamil nasal spray, marketed as Cardamyst, for the treatment of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults. This approval marks the first new treatment for PSVT in over
three decades, providing a self-administered option for patients outside of emergency settings. PSVT is a condition characterized by sudden episodes of rapid heart rate, affecting over 2 million Americans. The approval is based on data from a comprehensive clinical development program, including the Phase 3 RAPID trial, which demonstrated significant efficacy in converting PSVT episodes to normal sinus rhythm. The nasal spray is expected to be available in U.S. pharmacies by early 2026.
Why It's Important?
The approval of etripamil nasal spray represents a significant advancement in the management of PSVT, a condition that can severely impact quality of life due to its unpredictable nature and the need for emergency medical intervention. By allowing patients to self-administer treatment, the nasal spray could reduce the need for emergency department visits, thereby decreasing healthcare costs and improving patient autonomy. This development is particularly beneficial for those who experience frequent episodes and have underlying health conditions that complicate treatment. The introduction of this nasal spray could also pave the way for further innovations in the treatment of other cardiac arrhythmias, such as atrial fibrillation with rapid ventricular rate (AFib-RVR), which affects millions of Americans.
What's Next?
Following the FDA approval for PSVT, Milestone Pharmaceuticals plans to continue the development of etripamil for the treatment of AFib-RVR. The company aims to initiate a Phase 3 registrational program, building on the findings from the ReVeRA Phase 2 trial. This expansion could potentially address a significant unmet need in the management of AFib-RVR, which affects a substantial portion of the population. The success of etripamil in PSVT could influence future regulatory approvals and encourage further research into self-administered treatments for cardiac conditions.
