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FDA Approves Once-Daily Mydayis for ADHD in Adults and Adolescents

Amphetamine-containing product consists of drug-releasing beads

The FDA has given the nod to Mydayis (mixed salts of a single-entity amphetamine product, Shire), a once-daily treatment consisting of three different types of drug-releasing beads for patients 13 years of age and older with attention-deficit/hyperactivity disorder (ADHD). Mydayis is not intended for use in children 12 years of age and younger. Shire expects to launch the product in the United States in the third quarter of 2017.

The FDA’s approval of Mydayis was based on results from 16 clinical studies that evaluated the treatment in more than 1,600 patients, including adolescents (13–17 years of age) and adults with ADHD. In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD in both adults and adolescents. Improvement on the Permanent Product Measure of Performance, an objective, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at two or four hours post-dose and lasting up to 16 hours post-dose.

Mydayis, other amphetamine-containing medications, and methylphenidate have a high risk for abuse and can cause physical and psychological dependence. Medication is not appropriate for all individuals diagnosed with ADHD.

The most common adverse events associated with Mydayis in adults include insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety. In pediatric patients (13 years of age and older), the most common adverse events include insomnia, decreased appetite, decreased weight, irritability, and nausea.

ADHD is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. An estimated 4.4% of adults have ADHD in the U.S., which equates to 10.5 million individuals. Approximately 50% to 66% of children with ADHD may continue to have ADHD symptoms as adults.

Source: Shire; June 20, 2017.

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