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: 30 May 2024
Price :
$35
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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
- 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.
- 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.