Milestone Opens Real-World Chapter for CARDAMYST With RESET-PSVT

Share on Social Media

andy-hermawan-O1jUvZX9DOA-unsplash
Photo by Andy Hermawan on Unsplash

Milestone Pharmaceuticals announced the Phase 4 RESET-PSVT registry to evaluate real-world use of CARDAMYST (etripamil) nasal spray in adults with PSVT, enrolling about 450 patients across 20 sites.

Written By: Karthik Teja Macharla, PharmD

Reviewed By: Pharmacally Editorial Team

Milestone Pharmaceuticals Inc. announced the planned Phase 4 RESET-PSVT registry to generate real-world evidence on the use of CARDAMYST (etripamil) nasal spray in adults with Paroxysmal Supraventricular Tachycardia. The study design was presented at the Preventive Cardiovascular Nurses Association 2026 Cardiovascular Nursing Symposium in Scottsdale, Arizona, and will be led by the Duke Clinical Research Institute.

CARDAMYST received U.S. FDA approval in December 2025 and is commercially available in the United States. RESET-PSVT is expected to enroll about 450 adults across approximately 20 electrophysiology and cardiology sites, with enrollment planned by the end of 2026. The prospective observational registry will include patients prescribed CARDAMYST as well as those receiving other therapies, with both patients and providers completing outcome surveys.

The primary endpoint is to characterize real-world CARDAMYST use, including episode frequency, dosing patterns, and triggers for treatment. Secondary endpoints will compare CARDAMYST and non-CARDAMYST users across patient-reported quality of life, healthcare utilization, and episode characteristics. Exploratory analyses will assess prescribing trends and patient experience.

Milestone’s Chief Medical Officer David Bharucha said the registry aims to expand evidence beyond clinical trials by evaluating real-world treatment patterns, quality of life, and healthcare utilization.

Lead investigator Sean Pokorney of Duke and DCRI noted the study is designed to capture patient-reported outcomes and provide insight into real-world experience with PSVT management.

RESET-PSVT is intended to generate prospective real-world evidence following the recent approval of CARDAMYST. Results from the registry are expected to be presented at scientific conferences and published in peer-reviewed journals.

Milestone also indicated that an expert theatre session focused on the FDA-approved nasal spray for PSVT in adults is scheduled during the PCNA symposium.

Reference

Milestone Pharmaceuticals Announces RESET-PSVT Registry to Generate Real-World Evidence on CARDAMYST™ (etripamil) Nasal Spray in Patients With PSVT, 10 April 2026, Milestone Pharmaceuticals Announces RESET-PSVT Registry to Generate Real-World Evidence on CARDAMYST™ (etripamil) Nasal Spray in Patients With PSVT

About the Writer

Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.


Share on Social Media
Scroll to Top