The Food and Drug Administration (FDA) has approved Adhansia XR (methylphenidate HCl extended-release; Adlon Therapeutics), a central nervous system stimulant, for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older.

The approval of Adhansia XR was based on data from 4 clinical trials evaluating the safety and efficacy of the treatment in adult and pediatric patients. A study conducted in ADHD patients (N=90) in an adult workplace environment found that treatment with Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8, 11, and 16 hours post-dose (but not at 14 hours post-dose) in mean Permanent Measure of Productivity Total (PERMP-T) scores, an objective, validated skill-adjusted math test.

Results from an analog classroom trial in pediatric patients 6 to 12 years of age (N=147) showed that treatment with Adhansia XR led to a statistically significant response over placebo in mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined scores. Among patients 12 to 17 years of age, Adhansia XR was associated with a statistically significant treatment effect compared with placebo based on pediatric ADHD-5­ Rating Scale (RS) total score from baseline.

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The most common adverse reactions reported in adult clinical trials were insomnia, dry mouth, and decreased appetite. In pediatric trials, decreased appetite, insomnia, and decreased weight were reported in ≥5% and were twice the rate of placebo.

Adhansia XR is expected to be available later this year in 25mg, 35mg, 45mg, 55mg, 70mg, and 85mg extended-release capsules. The CII scheduled product should not be substituted for other methylphenidate products on a milligram-per-milligram basis because of different methylphenidate base composition and differing pharmacokinetic profiles.

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