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Milestone Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Clinical and Corporate Update
NDA submission for etripamil in patients with PSVT expected in October 2023Data featured during oral session at Heart Rhythm 2023 Annual Meeting support the
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"NDA submission for etripamil in patients with PSVT expected in October 2023Data featured during oral session at Heart Rhythm 2023 Annual Meeting support the potential of etripamil in patients with AFib-RVR Enrollment complete in Phase 2 ReVeRA study of etripamil in patients with AFib-RVR; topline data expected in fourth quarter of 2023MONTREAL and CHARLOTTE, N.C., Aug. 10, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the second quarter ended June 30, 2023, and provided a clinical and corporate update.\n\"The remainder of 2023 represents a transformative time for the Company as we approach our first New Drug Application (NDA) submission for etripamil and continue to lay the groundwork required to successfully launch what could serve as the first and only U.S. Food and Drug Administration (FDA) approved treatment for patients to self-treat their paroxysmal supraventricular tachycardia (PSVT),\" said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. \"Expanding assessment of the potential clinical utility of etripamil, we have completed enrollment in ReVeRA, our Phase 2 study of etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR), and we look forward to sharing topline data from this study in the fourth quarter of this year.\"\nRecent Program Updates\nEtripamil for PSVT\nNDA Submission for Etripamil Nasal Spray in Patients with PSVT Expected in October. Milestone expects to submit its first NDA for etripamil, the Company's investigational calcium channel blocker that is administered by patients outside of the healthcare setting, in patients with PSVT in October. Based on feedback from the FDA, data from the Company's previously completed global Phase 3 clinical program, including the RAPID and RAPID-extension studies, NODE-303 and NODE-301, are expected to fulfill the safety and efficacy requirements for the planned NDA submission.Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with PSVT Published in The Lancet. Results from the Company's Phase 3 RAPID clinical study were recently published in The Lancet. The publication, titled \"Self-administered Intranasal ...