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FDA Issues Complete Response Letter for Etripamil for PSVT
CRL focused on CMC; no clinical issues relating to etripamil raised $69.7M in cash, cash equivalents and short-term investments as of December 31, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S. Food and Drug Administration (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 conver
About this update from Milestone Pharmaceuticals Inc.
[{"type":"image","alt":"Milestone Pharmaceuticals Inc.","displaySize":"","headline":null,"caption":"Milestone Pharmaceuticals Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":57,"url":"https://media.zenfs.com/en/globenewswire.com/a3e01b195c1ef10ed327d66d987e808c"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/YgaHOGiuZH1uIXCqN0ZsAw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTgwO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/a3e01b195c1ef10ed327d66d987e808c","width":300,"height":57}},"lazy":false},{"type":"text","content":"CRL focused on CMC; no clinical issues relating to etripamil raised","length":67,"tagName":"p"},{"type":"text","content":"$69.7M in cash, cash equivalents and short-term investments as of December 31, 2024 ","length":83,"tagName":"p"},{"type":"text","content":"MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S. Food and Drug Administration (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.","length":410,"tagName":"p"},{"type":"text","content":"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:","length":179,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Company to submit additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission; and","length":131,"tagName":"p"}]},{"val":[{"type":"text","content":"An inspection is required at a facility that performs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.","length":218,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":349,"olType":false},{"type":"text","content":"“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...