Milestone Pharmaceuticals’ etripamil spray New Drug Application refused by FDA

Milestone Pharmaceuticals received a Refusal to File letter from the FDA for the New Drug Application for self-administered etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia. Upon preliminary review, the FDA determined that the NDA, submitted in October 2023, was not sufficiently complete to permit substantive review. The FDA requested clarification about the time of data recorded for adverse events in Phase 3 clinical trials; FDA did not express concerns about the nature or severity of adverse events. Milestone will seek clarification and is in the process of planning a meeting with the FDA.