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A Phase 3, Randomized, Double-blind, Multi-center, Placebo Controlled, Dose-Optimization, Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

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Trial Profile

A Phase 3, Randomized, Double-blind, Multi-center, Placebo Controlled, Dose-Optimization, Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Mixed amfetamine salts (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire

Most Recent Events

  • 20 Jun 2017 According to a Shire media release, the U.S. FDA has approved MYDAYIS (mixed salts of a single-entity amphetamine product) for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD), based on the results from 16 studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13-17 years) and adults with ADHD.
  • 19 Jan 2017 According to a Shire media release, the U.S. FDA has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies.
  • 04 Apr 2016 According to a Shire media release, the company is planning to include the data from this trial as a part of the FDA resubmission.

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