FDA isues a Complete Response Letter for Cardamyst (etripamil) nasal spray for the conversion of acute episodes of PSVT to sinus rhythm .- Milestone Pharma
Milestone Pharmaceuticals Inc. announced the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for Cardamyst (etripamil) 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 (CMC) 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- Company to submit additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission; and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.
“We are deeply disappointed by the CRL but remain committed to the potential of Cardamyst as a novel treatment option that can help patients with PSVT. Our team is evaluating the feedback provided and intends to request a Type A meeting to discuss the issues raised in the CRL,” said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We are appreciative of the FDA’s efforts and are confident we can collaborate with the agency with the goal of addressing these issues in a resubmission.”
Milestone Pharmaceuticals had $69.7M in cash, cash equivalents and short-term investments as of December 31, 2024.
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