Milestone Pharmaceuticals Advances Etripamil Nasal Spray into Phase…

Event summary

Milestone Pharmaceuticals has initiated the Phase 3 ReVeRA-301 trial for etripamil nasal spray to treat atrial fibrillation with rapid ventricular rate (AFib-RVR).
The trial will evaluate the same 70 mg repeat-dose regimen already FDA-approved for paroxysmal supraventricular tachycardia (PSVT).
The study aims to enroll approximately 150 patients across North America and internationally.
Primary endpoint is reduction in ventricular rate within 30 minutes, with secondary focus on symptom improvement.
Milestone is pursuing a single-study supplemental new drug application (sNDA) registration pathway for AFib-RVR.

The big picture

Milestone Pharmaceuticals is expanding the potential of its etripamil nasal spray beyond its current FDA-approved use for PSVT, targeting a larger market in AFib-RVR management. This Phase 3 trial represents a strategic pivot toward addressing a condition with substantial healthcare burden and limited self-administered treatment options. Success could position etripamil as a key player in cardiovascular care, potentially reducing emergency department reliance for millions of patients.

What we're watching

Regulatory Pathway: Whether the FDA will accept the single-study sNDA approach for AFib-RVR, given the existing approval for PSVT.
Trial Execution: The pace at which Milestone can enroll patients across global sites and meet the event-driven trial endpoints.
Market Adoption: How successful etripamil could be in reducing emergency department visits for AFib-RVR, addressing a significant unmet medical need.