Milestone Pharmaceuticals Expands Phase 3 Trial for AFib-RVR Treatment to Europe
Event summary
- First European patient enrolled in ReVeRA-301 Phase 3 trial for etripamil nasal spray in AFib-RVR treatment.
- Trial targets approximately 150 AFib-RVR patients across multiple sites.
- Study uses the same 70 mg repeat-dose regimen approved for PSVT in the U.S.
- Enrollment in the U.S. and Canada began in August 2026.
- Primary endpoint is reduction in ventricular rate within 30 minutes.
The big picture
Milestone Pharmaceuticals is advancing its Phase 3 trial for etripamil nasal spray, aiming to provide a self-administered treatment for AFib-RVR. This expansion into Europe follows successful enrollment in the U.S. and Canada, highlighting the company's strategic push to broaden its clinical footprint. The trial's outcomes could significantly impact the management of AFib-RVR, offering a novel alternative to current emergency department-based treatments.
What we're watching
- Trial Execution
- The pace at which Milestone can enroll the remaining patients and complete the trial will determine the timeline for potential regulatory approval.
- Regulatory Pathway
- Whether the single-study supplemental new drug application (sNDA) pathway will be accepted by the FDA for AFib-RVR treatment.
- Market Adoption
- How the self-administered, ambulatory-setting treatment approach will be received by patients and healthcare providers.