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Milestone Pharmaceuticals Progresses Clinical and Regulatory Activities for Etripamil in Patients with Paroxysmal Supraventricular Tachycardia
- Both the NODE-303 and RAPID-extension studies are complete - Following FDA feedback, Etripamil NDA is on-track for submission in the third quarter of 2023 -
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"- Both the NODE-303 and RAPID-extension studies are complete\n- Following FDA feedback, Etripamil NDA is on-track for submission in the third quarter of 2023\n- Potential to be the first fast-acting, patient administered treatment to break PSVT episodes if approved\nMONTREAL and CHARLOTTE, N.C., March 6, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced significant progress in clinical and regulatory activities for etripamil, the Company's investigational calcium channel blocker that is administered by patients outside of the healthcare setting to treat paroxysmal supraventricular tachycardia (PSVT).\nData from the completed NODE-303 open-label safety and RAPID extension studies will be included in the etripamil PSVT New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) which is expected in the third quarter of 2023. The Company believes feedback received from the FDA supports and aligns with its proposed approach for the NDA.\n\"With the completion of the NODE-303 and RAPID-extension studies and the recent feedback from the FDA, we are confident we have the necessary data for an NDA submission in the third quarter of 2023,\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"I would like to thank all those involved in the global phase 3 clinical program for the timely achievement in our quest to help patients suffering with PSVT.\" \n\"We believe that etripamil is uniquely positioned, if approved, to make a new treatment available to patients with PSVT who currently face highly symptomatic, unpredictable, and burdensome episodes of this cardiac arrhythmia. Allowing patients to take control of their condition with a self-administered, on-demand treatment will represent value – both towards patients' empowerment and potentially to the healthcare system, due to a reduced dependence on emergency department and other healthcare resources to treat PSVT,\" said David Bharucha, M.D., Ph.D., F.A.C.C., Chief Medical Officer of Milestone Pharmaceuticals. \"We look forward to analysis of the data from the NODE-303 and RAPID-extension studies and are keenly focused on advancing our NDA submission which could result in the ...