Shares of Milestone Pharmaceuticals (NASDAQ: MIST) soared in pre-market trading on Monday after the biopharmaceutical company announced positive topline data from the Phase 3 RAPID clinical trial of etripamil. Etripamil is Milestone’s investigational calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT).
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Supraventricular tachycardia is an abnormally fast heartbeat.
Milestone’s randomized, double-blind, placebo-controlled Phase 3 trial data met its primary endpoint with 64.3% of patients self-administering etripamil converting to sinus rhythm within 30 minutes compared to 31.2% on placebo. This trial enrolled 706 patients.
An analysis of pooled data from the NODE -301 and RAPID trials also indicated a statistically significant reduction in medical interventions and visits to the emergency department for patients treated with etripamil.
MIST plans to submit a New Drug Application (NDA) to the U.S. FDA by the middle of next year.