Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). PVST is a condition characterized by an abnormality in the electrical system of the heart causing patients to have unexpected, often severely symptomatic episodes of rapid heart rate.
Representing the largest data package ever studied in PSVT, the Company believes the clinical trial program demonstrates that etripamil provided superior time to conversion to normal heart rhythm compared to placebo. The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.
“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,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “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 FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review. If accepted, Milestone Pharmaceuticals expects a standard review of 10 months of the company’s NDA. Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST™. The brand name is conditionally approved by the FDA.