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Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study

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Trial Profile

Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Oct 2021

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At a glance

  • Drugs Viloxazine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Therapeutic Use
  • Sponsors Supernus Pharmaceuticals

    • Most Recent Events

    • 22 Feb 2021 According to a Supernus Pharmaceuticals media release, the company will continue to work closely with the FDA as it completes its review of the SPN-812 NDA. If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.
    • 22 Feb 2021 According to a Supernus Pharmaceuticals media release, the company received notice from the U.S. FDA that the companys New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021.
    • 08 Feb 2021 According to a Supernus Pharmaceuticals media release, the FDA will classify the NDA resubmission as Class I or Class II upon acceptance of the resubmission.

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