Milestone Pharmaceuticals Expands Phase 3 Trial for Etripamil Nasal Spray into Canada
Event summary
- Milestone Pharmaceuticals has enrolled the first Canadian participant in its ReVeRA-301 Phase 3 trial for etripamil nasal spray to treat AFib-RVR.
- The trial aims to enroll 150 patients across multiple countries, with the Montreal Heart Institute as the first Canadian site.
- Etripamil is already FDA-approved for PSVT under the brand name CARDAMYST.
- The study evaluates the same 70 mg repeat-dose regimen used in the FDA-approved indication.
The big picture
Milestone Pharmaceuticals is expanding its Phase 3 trial for etripamil nasal spray into Canada, a strategic move to accelerate enrollment and support its regulatory ambitions. The trial's success could position etripamil as a novel self-administered treatment for AFib-RVR, addressing a significant unmet need in cardiovascular care. The company's ability to leverage its existing FDA approval for PSVT could streamline the regulatory process, but the trial's outcomes will be critical in determining its broader market potential.
What we're watching
- Trial Momentum
- The pace at which Milestone can enroll participants across international sites will determine the trial's timeline and potential regulatory approval.
- Regulatory Pathway
- Whether the single-study supplemental new drug application (sNDA) pathway for AFib-RVR will be accepted by the FDA remains a key uncertainty.
- Market Adoption
- How the self-administered nature of etripamil nasal spray will influence patient compliance and market adoption for AFib-RVR treatment.