Milestone Pharmaceuticals announced that the FDA has approved Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the company expects to launch the product in early 2026. Milestone submitted the NDA for Cardamyst in October 2023 and announced that it had received a Refuse to File letter to that application from the FDA in December 2023. The company resubmitted the NDA in March 2024, and the FDA issued a complete response letter to the application in March 2025. Milestone submitted its response to the CRL in June 2025.
Milestone also said that it now plans to initiate Phase 3 development of intranasal etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR). A Phase 2 trial of etripamil for AFib-RVR concluded in 2023 met its primary endpoint. According to the announcement, the company intends to submit an sNDA for the AFib-RVR indication if the Phase 3 trial is successful.
Milestone President and CEO Joseph Oliveto commented, “Cardamyst is a novel at-the-ready treatment option that addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere. The FDA approval of Cardamyst is a watershed moment for Milestone and a gratifying event for our team members, patients, clinical investigators, and health care providers who participated in the development program, all of whom I sincerely thank for their dedication, counsel, and collaboration toward this important achievement.”
Chief Commercial Officer Lorenz Muller said, “Our goal is that Cardamyst will become a trusted and essential solution for healthcare providers and their patients. Our team is focused on making Cardamyst available to adults with PSVT as quickly as possible, including actively working to secure insurance coverage and begin the distribution of the product through retail pharmacies.”
Read the Milestone Pharmaceuticals press release
