- Milestone Pharmaceuticals has enrolled the first Canadian patient in the Phase 3 ReVeRA-301 trial evaluating etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR).
- The Montreal Heart Institute is the first Canadian clinical trial site, contributing to the multinational study targeting 150 patients with treated AFib-RVR events.
- ReVeRA-301 is evaluating a 70 mg repeat-dose regimen of etripamil, the same regimen approved by the FDA for paroxysmal supraventricular tachycardia (PSVT) as Cardamyst.
- The trial expansion into Canada builds on Phase 2 data and is assessing the potential of self-administered etripamil nasal spray to enable rapid treatment of AFib-RVR outside the emergency department.
Takeaways:
Enrolling the first Canadian patient in ReVeRA‑301 advances Milestone’s plan to seek a single‑study sNDA for etripamil in AFib‑RVR, a substantially larger market than its approved PSVT indication (CARDAMYST) and one the company estimates at ~3–4 million addressable patients by 2030. If the 70 mg repeat‑dose nasal spray shows rapid ventricular‑rate reduction within 30 minutes and symptom relief, it could shift a portion of acute AFib‑RVR care out of the emergency department (where 30–40% of AF patients have ≥1 RVR episode/year), creating a high‑value, self‑administered franchise and diversifying Milestone’s revenue beyond PSVT.
Source: Globenewswire
