Milestone files NDA for etripamil; Phase 3 showed 2x efficacy, 3x speed vs placebo

Milestone Pharmaceuticals Inc.

Submitted NDA to FDA for etripamil (CARDAMYST) for paroxysmal supraventricular tachycardia (PSVT) on Oct 24, 2023.
Pivotal Phase 3 RAPID trial published in The Lancet; etripamil restored normal rhythm 2x more effectively and 3x faster than placebo.
FDA 60-day filing review period to determine completeness; if accepted, standard 10-month review expected.
Brand name CARDAMYST conditionally approved by FDA; commercial preparations underway for anticipated launch.

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