Officials with Shire announced that the FDA has approved mixed salts of a single-entity amphetamine product (Mydayis), a once-daily treatment comprised of 3 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.
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.
In phase 3 clinical studies where efficacy was the primary endpoint, a morning dose of Mydayis demonstrated superiority to placebo based on the change from baseline in the ADHD-RS-IV total score for adult and adolescent patients, respectively, according to a statement from Shire. The most common adverse reactions associated with Mydayis (incidence ≥5% and at a rate at least twice placebo) in adults are insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety. For pediatric patients (13 years and older), the most common adverse reactions were insomnia, decreased appetite, decreased weight, irritability, and nausea.
Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.
U.S. FDA Approves Mydayis™ (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Olders [news relase] Shire website. Accessed at: https://www.shire.com/newsroom/2017/june/w6x937