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.
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.
For more information visit adlontherapeutics.com.