According to Milestone Pharmaceuticals, the FDA has refused to file the company’s NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and has “requested clarification about the time of data recorded for adverse events” during Phase 3 trials. Milestone submitted the NDA in October 2023.
Milestone initiated the Phase 3 RAPID trial of etripamil in November 2020 and announced that the study met its primary endpoint in October 2022. A previous Phase 3 trial, NODE-301, missed its primary endpoint.
Milestone President and CEO Joseph Oliveto commented, “We intend to work with the FDA to better understand the open issues and to agree on a path forward. We are committed to advancing etripamil nasal spray as a first-of-its kind portable and fast acting solution that would allow patients with episodic cardiovascular conditions to actively self-manage their condition outside of the healthcare setting.”
Read the Milestone Pharmaceuticals press release.
