A phase III safety and efficacy trial of SHP465 in adults with Attention-Deficit Hyperactivity Disorder (ADHD)
Phase of Trial: Phase III
Latest Information Update: 20 Jun 2017
At a glance
- Drugs Mixed amfetamine salts (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Shire
- 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.
- 20 May 2016 New trial record
- 04 Apr 2016 According to a Shire media release, Shire plans to add these study results to its existing SHP465 data set to submit a Class 2 resubmission for FDA approval of the medicine for treatment of ADHD.