FDA approves Midayis (mixed salts of a single-entity amphetamine product) a once daily treatment for ADHD.- Shire plc.

Shire plc has announced that the FDA has approved Midayis (mixed salts of a single-entity amphetamine product), a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and younger. Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.

The FDA approval of Mydayis is based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD. In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hours post-dose.

The drug has the same active ingredient as Adderall XR (mixed amphetamine salts), but is designed to provide symptom control for adults with ADHD for up to 16 hours as opposed to the 12 to 14 hours currently offered by alternative treatments.