Milestone Pharmaceuticals has announced the initiation of the Phase 3 ReVeRA-301 study of etripamil nasal spray in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR). The trial is expected to enroll about 150 patients who will be able to self administer etripamil if they experience systems. In November 2023, Milestone announced that the the Phase 2 ReVeRA trial etripamil for the treatment of AFib-RVR had met its primary endpoint.
If ReVeRA-301 is successful, the company says that it plans to submit an sNDA to extend the use of the nasal spray to add AFib-RVR. Cardamyst was approved by the FDA for the treatment of paroxysmal supraventricular tachycardia (PSVT) in December 2025, and Milestone launched the nasal spray in the US in January 2026. In Europe, the EMA has accepted the company’s MAA for intranasal etripamil for the treatment of PVST.
Milestone Chief Medical Officer David Bharucha commented, “Enrolling the first patient in the ReVeRA-301 Phase 3 trial marks an important point in the development of etripamil for patients with AFib-RVR. The FDA approval of etripamil for the treatment of acute, episodic PSVT in adults, and the promising Phase 2 data in patients with AFib-RVR, provide a strong foundation as we advance our clinical development program and evaluate etripamil in this area of substantial unmet medical need. We are activating clinical trial sites across North America and internationally to support efficient enrollment in this event-driven, global Phase 3 study. Today’s announcement is an exciting step forward in our efforts to address a significant unmet need in cardiovascular care.”
Principal Investigator James Ip of Weill Cornel Medicine said, “Current management of AFib-RVR in the United States places a substantial burden on both patients and healthcare systems. Because patients experiencing AFib-RVR have no optimally effective self-administered treatment options, many of them require evaluation and treatment in the emergency department. We are eager to determine if we can clinically validate a safe and effective self-administered treatment option that could reduce reliance on emergency department care for the millions of patients living with AFib-RVR.”
Read the Milestone Pharmaceuticals press release
