A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Trial Profile

A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2017

At a glance

  • Drugs Dasotraline (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Sunovion Pharmaceuticals
  • Most Recent Events

    • 10 Nov 2017 According to a Sunovion Pharmaceuticals Media Release, U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults, based on the data from multiple placebo-controlled safety and efficacy studies, as well as two long-term studies
    • 13 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, based on positive data from this trial and discussions with the U.S. FDA, company intends to submit a New Drug Application (NDA) to the FDA in 2017 for ADHD in children and adults.
    • 13 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, full results of study SEP360-221 and study SEP360-301 are being analyzed and will be presented at upcoming scientific meetings.
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