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Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The RAPID Study (NODE-301 Part 2)

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Trial Profile

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The RAPID Study (NODE-301 Part 2)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2025

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At a glance

  • Drugs Etripamil (Primary)
  • Indications Paroxysmal supraventricular tachycardia
  • Focus Registrational; Therapeutic Use
  • Acronyms NODE-301 Part 2; RAPID
  • Sponsors Milestone Pharmaceuticals

Most Recent Events

  • 16 Jun 2025 According to a Milestone Pharmaceuticals media release, the review time is expected to be within 2 or 6 months from the resubmission, depending on the classification.
  • 16 Jun 2025 According to a Milestone Pharmaceuticals media release, Company announced submission of its response to the U.S. Food and Drug Administration Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYS nasal spray for the paroxysmal supraventricular tachycardia.The response follows a Type A meeting recently held with the FDA. The acceptance of the response and corresponding (PDUFA) date will be determined within the next thirty days per FDA policy.
  • 11 Feb 2025 According to a Milestone Pharmaceuticals media release, company announced that the New Drug Application (NDA) for CARDAMYST is currently under review at the U.S. Food and Drug Administration (FDA). The company expects to launch CARDAMYST in PSVT mid-2025.

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