The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.
The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the 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 reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.
In the phase III studies, 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. The most common adverse reactions reported with Mydayis in adults were insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety (incidence less than 5% and at a rate at least twice that of placebo). For pediatric patients, the most common adverse reactions were insomnia, decreased appetite, decreased weight, irritability, and nausea.
The medication, an amphetamine product, consists of three different types of drug-releasing beads.
“With this approval, we hope to help patients who need a once-daily treatment option,” Flemming Ornskov, MD, MPH, said in a press release. Dr. Ornskov is CEO of Shire.
It is estimated that 4.4% of adults have ADHD in the United States, and 50%-66% of children with ADHD may continue to have symptoms of the disorder as adults.
Mydayis will be commercially available in the United States in the third quarter of 2017.
Read the full press release here .