Milestone Pharmaceuticals announced that it has received a complete response letter from the FDA in regard to the company’s NDA for Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone first submitted the NDA in October 2023 and re-submitted the NDA in March 2024 after the FDA refused to accept the initial application.
According to Milestone, the CRL cites a need for additional data on nitrosamine impurities and for a cGMP inspection of the laboratory that does release testing for the nasal spray. The company emphasized that the agency did not request any additional clinical data.
Milestone President and CEO Joe Oliveto commented, “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. 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.”
Read the Milestone Pharmaceuticals press release
