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Milestone Pharmaceuticals Initiates Pivotal Phase 3 Trial of Etripamil Nasal Spray for Self-Administered Treatment of Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR)

MIST
  • Milestone Pharmaceuticals enrolled the first patient in the ReVeRA-301 Phase 3 pivotal trial evaluating etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR).
  • The trial utilizes the same 70 mg repeat-dose regimen of etripamil nasal spray that is FDA-approved for paroxysmal supraventricular tachycardia (PSVT) under the brand CARDAMYST.
  • ReVeRA-301 is a multinational, randomized, double-blind, placebo-controlled study targeting approximately 150 patients who will self-administer the treatment in a medically unsupervised setting.
  • The primary endpoint is reduction in ventricular rate within 30 minutes, while secondary endpoints assess symptom improvement via patient-reported outcomes.
  • Milestone is pursuing a single-study supplemental new drug application (sNDA) registration pathway for AFib-RVR based on the trial results.
  • The Phase 3 study builds on ReVeRA-201 Phase 2 findings where etripamil reduced ventricular rate and improved symptom relief and treatment satisfaction in an emergency room setting.
  • Current AFib-RVR management often requires emergency department visits for IV medications or cardioversion, placing a substantial economic burden on the U.S. healthcare system.
  • CARDAMYST is currently indicated for the conversion of acute PSVT episodes to sinus rhythm in adults, with Phase 3 development ongoing for AFib-RVR control.
  • Safety information for CARDAMYST warns against use in patients with heart failure, specific conduction abnormalities like WPW syndrome, sick sinus syndrome without a pacemaker, or second-degree AV block.
  • Common side effects of CARDAMYST include nasal discomfort, congestion, runny nose, throat irritation, and nosebleeds.