Milestone Pharmaceuticals has published data from the Phase 2 ReVeRA trial of etripamil nasal spray in patients experiencing atrial fibrillation with rapid ventricular rate (AFib-RVR) that the company says “support further development of self-administered etripamil for the treatment of AFib-RVR.” The article appeared in the journal Circulation: Arrhythmia and Electrophysiology. Milestone recently submitted an NDA seeking FDA approval for the use of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT).
The ReVeRA study enrolled 56 adult patients with atrial fibrillation who received either etripamil or a placebo nasal spray in hospital emergency departments. According to Milestone, the study met its primary endpoint, with a difference in the mean reduction of ventricular rate between patients receiving etripamil and those receiving placebo of 30 beats per minute. Maximum reduction in ventricular rate for patients receiving etripamil was 35 beats per minute compared to a maximum reduction of 5 beats per minute for placebo, and median time to maximum reduction for etripamil users was 13 minutes.
Milestone Pharmaceuticals Chief Medical Officer David Bharucha commented, “The results from the ReVeRA study are promising and demonstrate the potential of etripamil nasal spray to rapidly reduce heart rate and provide symptomatic benefit to patients suffering from AFib-RVR. We believe our recent NDA submission for etripamil for the potential treatment of PSVT, as well as FDA guidance received on AFib-RVR, provide a strong foundation for the continued clinical development of patient-administered etripamil with a Phase 3 study in AFib-RVR.”
Read the Milestone Pharmaceuticals press release.
