Milestone Pharmaceuticals Inc. announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company's lead investigational product for the management of paroxysmal Supraventricular tachycardia (PSVT). The NDA for etripamil was resubmitted based on guidance from the FDA obtained in a Type A meeting, which was conducted after receipt of a Refusal to File (RTF) letter. The resubmission package included restructured data sets that captured timing of reported AEs and certain data files reformatted to facilitate FDA's analyses.

No additional efficacy or safety data were requested as part of the RTF. An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition.

CARDAMYST??, the previously approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR.