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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: 24 Dec 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

  • 14 Dec 2025 According to a Milestone Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) approved its first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
  • 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.

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