FDA Issues Complete Response Letter for Etripamil for PSVT

Core Viewpoint - Milestone Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, which is intended for the treatment of acute episodes of PSVT in adults, with no clinical safety or efficacy issues raised by the FDA [1][2] Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to improve the lives of patients with complex heart conditions [4] - The company's lead investigational product, etripamil, is a novel calcium channel blocker nasal spray designed for self-administration to treat symptomatic episodes associated with PSVT and AFib-RVR [3][4] Financial Position - As of December 31, 2024, Milestone Pharmaceuticals had $69.7 million in cash, cash equivalents, and short-term investments [1][2] Regulatory Feedback - The FDA's CRL highlighted two key Chemistry, Manufacturing and Controls (CMC) issues that need to be addressed, but did not raise concerns regarding the clinical safety or efficacy of etripamil [2][6] - The company plans to request a Type A meeting with the FDA to discuss the issues raised in the CRL and is committed to addressing these concerns for a potential resubmission [2][6] Product Development - Etripamil is designed as a self-administered rapid response therapy, allowing patients to manage their condition without immediate medical oversight [3] - The product has undergone a robust clinical trial program, including a completed Phase 3 clinical-stage program for PSVT and a Phase 2 trial for AFib-RVR [3]