Milestone Pharmaceuticals Initiates RESET-PSVT Phase 4 Registry for Recently Approved CARDAMYST, Targeting 450 Patients
Milestone Pharmaceuticals Inc. announced the initiation of RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry for its recently FDA-approved CARDAMYST™ (etripamil) nasal spray. The registry aims to generate real-world evidence on CARDAMYST's use in adults with paroxysmal supraventricular tachycardia (PSVT), expanding beyond controlled clinical trials. Led by the Duke Clinical Research Institute, the study is expected to enroll approximately 450 adult patients across 20 electrophysiology and cardiology sites, with enrollment commencing by the end of 2026. This initiative is crucial for understanding CARDAMYST's utilization in routine care, capturing patient-reported outcomes, and informing healthcare providers about its value in acute PSVT management.
Key Highlights
- Milestone Pharmaceuticals announced RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry for CARDAMYST™ (etripamil) nasal spray in adults with PSVT.
- CARDAMYST was approved by the U.S. FDA in December 2025 and is now commercially available.
- The registry will be led by the Duke Clinical Research Institute (DCRI) and is expected to enroll an estimated 450 adult patients across approximately 20 electrophysiology and cardiology sites.
- Enrollment for RESET-PSVT is anticipated to begin by the end of 2026.
- The primary endpoint is to characterize patterns of CARDAMYST use, including frequency of PSVT episodes, frequency of use, number of doses administered per episode, and triggers for use.
- Secondary endpoints include comparisons between CARDAMYST and non-CARDAMYST users across patient-reported quality of life, healthcare utilization, and episode characteristics.
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