Milestone Pharmaceuticals announces FDA issued CRL for etripamil

Milestone Pharmaceuticals (MIST) announced the U.S. Food and Drug Administration, FDA, issued a Complete Response Letter, CRL, regarding its New Drug Application, NDA, for CARDAMYST nasal spray, a prescription medication in development for the conversion of acute episodes of PSVT to sinus rhythm in adults. The FDA did not raise any concerns regarding etripamil clinical safety or efficacy data and highlighted two key Chemistry, Manufacturing and Controls issues to be addressed: Company to submit additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission; and An inspection is required at a facility that performs release testing for etripamil, to ensure it is in compliance with Current Good Manufacturing Practices. The facility changed ownership during the review of the NDA.