1 March 2019 - In a simulated workplace environment study in adult patients with ADHD, Adhansia XR demonstrated statistically significant improvement in attention over placebo at one hour and at 16 hours post-dose.

Adlon Therapeutics announced that the U.S. FDA approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system stimulant, for the treatment of attention deficit -hyperactivity disorder (ADHD) in patients six years and older. In a simulated adult workplace environment study, Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose.

The FDA approval of Adhansia XR was based on four clinical studies evaluating the efficacy and safety of Adhansia XR in patients who met DSM-5 criteria for ADHD.

Read Adlon Therapeutics press release