Milestone Pharmaceuticals has commenced a pivotal Phase III trial of its etripamil nasal spray aimed at treating atrial fibrillation with rapid ventricular rate (AFib-RVR).
The ReVeRA-301 study has enrolled its first patient. It will assess the effects of etripamil on approximately 150 patients with AFib-RVR.
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This trial employs a multinational, multi-centre, randomised, double-blind, and placebo-controlled approach.
Patients will self-administer a 70mg dose of the nasal spray, repeating doses according to the regimen approved by the US Food and Drug Administration (FDA) for treating paroxysmal supraventricular tachycardia (PSVT).
Milestone is pursuing a supplemental new drug application (sNDA) for this potential new use of etripamil. The primary goal of the ReVeRA-301 study is to achieve a reduction in ventricular rate within 30 minutes, with secondary measures focusing on symptom improvement as reported by patients.
Milestone Pharmaceuticals chief medical officer David Bharucha said: “The FDA approval of etripamil for the treatment of acute, episodic PSVT in adults, and the promising Phase II data in patients with AFib-RVR, provide a strong foundation as we advance our clinical development programme 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 III study. Today’s announcement is an exciting step forward in our efforts to address a significant unmet need in cardiovascular care.”
The study builds on earlier research from the ReVeRA-201 Phase II study that evaluated the nasal spray’s efficacy and safety in reducing symptoms of AFib-RVR in emergency settings. Results indicated that a single 70mg dose reduced ventricular rate and enhanced symptom relief and patient satisfaction.
Etripamil is already FDA-approved for converting acute episodes of PSVT in adults, marketed under the name Cardamyst.
Atrial fibrillation is the most common persistent arrhythmia, affecting more than six million people in the US. It is characterised by an irregular heart rate, with classifications, including paroxysmal, persistent, and permanent forms.
