Milestone Pharmaceuticals said that it has submitted an NDA for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the FDA has conditionally approved the proposed trade name “Cardamyst.” The company said that it is continuing preparations for an anticipated commercial launch.
According to Milestone, the clinical program for etripamil resulted in “the largest data package ever studied in PSVT.” In October 2022, Milestone announced that the Phase 3 RAPID trial of intranasal etripamil met its primary endpoint. The RAPID trial was initiated in November 2020 after the FDA agreed to modifications to the study design of the ongoing NODE-301B study. The modifications took place after the Phase 3 NODE-301 trial missed its primary endpoint.
Milestone President and CEO Joseph Oliveto commented, “With the achievement of our first NDA submission, we want to thank the investigators, clinical trial teams, our colleagues and, most importantly, patients whose contributions were critical to completing our registration trials. With this submission, we are one step closer to getting etripamil into the hands of patients who are seeking a new treatment option that will allow them to take an active role in managing their PSVT.”
The company also said that it will soon report results from a proof of concept study of etripamil for the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR).
Read the Milestone Pharmaceuticals press release.
