Milestone Pharmaceuticals said that the phase 3 RAPID clinical trial of etripamil nasal spray in paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint.
The multi-centre, randomised, double-blind, and placebo-controlled trial of the investigational calcium channel blocker enrolled 706 individuals at clinical sites in North America and Europe.
Milestone Pharmaceuticals said that patients were randomised 1:1 to receive either a etripamil nasal spray or a placebo without any kind of medical supervision. Patients who did not experience relief from their symptoms within 10 minutes were instructed to self-administer a repeat dosage of the investigational drug to maximise its potential therapeutic impact.
Patients subjected to etripamil showed a statistically significant difference in time to PSVT conversion compared to placebo, thus achieving the primary endpoint of the RAPID study.
A Kaplan Meier analysis showed that 64.3% of patients self-administering etripamil converted to sinus rhythm within 30 minutes compared to 31.2% on placebo, the firm said.
Apart from that, the median time to conversion for patients in the late-stage trial who took etripamil was faster by three times than for patients in the placebo arm.
Milestone Pharmaceuticals president and CEO Joseph Oliveto said: “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 U.S. Food and Drug Administration (FDA) to make available what we believe is the first of its kind, self-administered therapy.”
The safety and tolerability data of etripamil nasal spray in the RAPID trial were consistent with what was noted in previous trials.
The biopharmaceutical company plans to submit a new drug application (NDA) for etripamil in patients having PSVT in mid-2023.
