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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. NODE-301 Trial

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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. NODE-301 Trial

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 23 Jul 2025

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At a glance

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

Most Recent Events

  • 11 Jul 2025 According to a Milestone Pharmaceuticals media release, Company announced that the U.S. Food and Drug Administration (FDA) has accepted for review company's response to issues raised in the Complete Response Letter (CRL) for CARDAMYS (etripamil) nasal spray for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025.
  • 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.

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