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:
Completed
Phase of Trial:
Phase III
Latest Information Update: 03 Apr 2024
Price :
$35
*
At a glance
- Drugs Etripamil (Primary)
- Indications Paroxysmal supraventricular tachycardia
- Focus Registrational; Therapeutic Use
- Acronyms NODE-301; RAPID
- Sponsors Milestone Pharmaceuticals
- 28 Mar 2024 According to a Milestone Pharmaceuticals media release, the company has resubmitted the New Drug Application for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT), based on guidance from the FDA obtained in a Type A meeting. The resubmission package included restructured data sets that captured timing of reported AEs and certain data files reformatted to facilitate FDA's analyses. No additional efficacy or safety data were requested.
- 26 Feb 2024 According to a Milestone Pharmaceuticals media release, company plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT). Following the previously announced receipt of a Refusal to File letter, company held a Type A Meeting with FDA.The Company expects a standard NDA review period following resubmission of the NDA for etripamil for PSVT, which is planned for 2Q 2024.
- 13 Nov 2023 According to a Milestone Pharmaceuticals media release, the FDA determination of whether the NDA is complete and accepted for review is expected by the end of 2023.