Milestone Pharmaceuticals has announced the initiation of the RAPID Phase 3 trial of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). A previous Phase 3 trial, NODE-301, failed to meet its primary endpoint. In July 2020, Milestone announced that it had reached an agreement with the FDA on the design of the RAPID study (formerly NODE-301B).
The redesigned trial is expected to enroll as many as 500 patients who will receive a dose of either etripamil nasal spray or placebo. If symptoms are not relieved within 10 minutes, patients will receive a second dose. The primary endpoint will be time to conversion of SVT within 30 minutes post dose, and the trial will conclude after 180 confirmed SVT events. The company expects to report data from the trial by early 2022, with results possible in late 2021.
Milestone Pharmaceuticals CEO Joseph Oliveto commented, “Commencement of RAPID marks an important milestone for the PSVT etripamil program. We remain very encouraged by physicians’ reactions to the safety and efficacy results from the NODE-301 trial and believe the RAPID trial has the potential to demonstrate increased efficacy and improved overall clinical utility of etripamil. We appreciate and thank the clinical investigators, trial coordinators, etripamil trial team, and patients for their contributions and continued support of RAPID.”
Read the Milestone Pharmaceuticals press release.
