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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: 22 Jul 2024

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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

    • 12 Jul 2024 Status changed from completed to discontinued.
    • 29 May 2024 According to a Milestone Pharmaceuticals media release, company announced that the United States Food and Drug Administration (FDA) accepted the Companys New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, for the management of paroxysmal supraventricular tachycardia (PSVT). The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024 (27 Mar 2025)
    • 02 May 2024 According to a Milestone Pharmaceuticals media release, an analysis form this trial will be presented at the Heart Rhythm 2024 Poster Presentation.

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