According to Milestone Pharmaceuticals, the Phase 3 RAPID (formerly NODE 301b) trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint, demonstrating that almost two thirds of patients using etripamil converted to sinus rhythm within half an hour while less than a third of patients using a placebo nasal spray achieved that conversion in the same amount of time. The company says that it plans to submit an NDA for the nasal spray in mid-2023.
When the RAPID 3 trial was initiated in November 2020, it was expected to enroll up to 500 patients with PSVT. The trial actually enrolled 706 patients in the US and Europe who self-administered either etripamil or a placebo nasal spray without medical supervision. Patients whose symptoms continued more than 10 minutes post dose were told to use a second dose. In addition to demonstrating a significantly higher rate of conversion to sinus rhythm within 30 minutes for patients using etripamil, the study also found that patients using etripamil converted three times as fast than patients using placebo and there was a statistically significant reduction in emergency room visits for patients using etripamil. No serious adverse events were reported, the company said.
Milestone Pharmaceuticals President and CEO Joseph Oliveto commented, “Today marks an important achievement for Milestone and for patients with PSVT. We believe that etripamil, if approved, has the potential to empower patients to take control of their condition as well as provide value to the healthcare system, in part by reducing visits to the emergency department. We look forward to working with the US Food and Drug Administration (FDA) to make available what we believe is the first of its kind, self-administered therapy. On behalf of the Milestone team, I would like to thank the patients, their caregivers, and the healthcare professionals who took part in the RAPID trial.”
The NODE-303 open label safety trial, which was initiated in 2019, is still enrolling patients Milestone noted.
Read the Milestone Pharmaceuticals press release.
