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Milestone starts Phase 3 AFib trial
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Milestone starts Phase 3 AFib trial

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  • Milestone Pharmaceuticals enrolled the first patient in its Phase 3 ReVeRA-301 trial evaluating etripamil nasal spray for AFib-RVR.
  • The multinational study will enroll approximately 150 patients and assess ventricular rate reduction within 30 minutes.
  • Milestone is pursuing a single-study sNDA pathway based on prior Phase 2 results for etripamil.

Milestone Pharmaceuticals (NASDAQ:MIST) enrolled the first patient in ReVeRA-301, a pivotal Phase 3 trial evaluating etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR).

The randomized, double-blind, placebo-controlled multinational study will include approximately 150 patients who will self-administer a 70 mg repeat-dose regimen of etripamil.

The trial’s primary endpoint is ventricular rate reduction within 30 minutes after treatment, while a key secondary endpoint measures symptom improvement.

Milestone said the etripamil regimen used in ReVeRA-301 is the same 70 mg repeat-dose approach approved by the FDA for paroxysmal supraventricular tachycardia (PSVT) under the CARDAMYST brand.

The company is pursuing a single-study supplemental New Drug Application (sNDA) pathway for AFib-RVR, supported by prior Phase 2 data.

Milestone said previous Phase 2 results showed reductions in ventricular rate, improved symptom relief and higher treatment satisfaction among patients receiving etripamil.

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