FDA Approves New ADHD Treatment Option

The FDA has approved Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment option comprised of 3 types of drug-releasing beads, for the treatment of patients aged 13 years and older with attention deficit hyperactivity disorder (ADHD).
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The approval is based upon the results of 16 clinical studies including data from more than 1600 adolescents and adults over 13 years of age with ADHD. In placebo-controlled clinical studies, Mydayis significantly improved ADHD-RS-IV and Permanent Product Measure of Performance scores in both adults and adolescents. PERMP improvement reached statistical significant at 2 or 4 hours post-dose, and remained for up to 16 hours post-dose.

The most common adverse effects associated with Mydayis use are trouble sleeping, decreased appetite, dry mouth, increased heart rate, anxiety, nausea, irritability, and weight loss.

—Michael Potts

Reference:

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 Older [press release]. Lexington, Massachusetts. June 20, 2017. https://www.shire.com/en/newsroom/2017/june/w6x937.