Milestone Pharmaceuticals Submits Response to the FDA's CRL for CARDAMYST (etripamil) Nasal Spray for PSVT Following Type A Meeting

Core Viewpoint - Milestone Pharmaceuticals has submitted a response to the FDA's Complete Response Letter regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, with a new PDUFA date expected within the year [1][2]. Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to enhance the lives of individuals with complex heart conditions [4]. - The company emphasizes understanding unmet patient needs and improving patient experiences through new treatment approaches that allow for self-management [4]. Product Information - Etripamil is the lead investigational product of Milestone, designed as a novel calcium channel blocker nasal spray for the rapid treatment of symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular response (AFib-RVR) [3]. - If approved, CARDAMYST™ will be the first self-administered therapy for the rapid termination of PSVT episodes, providing patients with greater control over their condition [2][3]. Regulatory Interaction - A recent Type A meeting with the FDA was deemed productive, providing necessary guidance for the resubmission of the NDA [2]. - The FDA's acceptance of the response and the determination of the new PDUFA date will occur within the next thirty days, with a review period expected to be between 2 to 6 months from resubmission [1].