FDA Approves ADHD Drug Adhansia HR

The Food and Drug Administration (FDA) in February approvedAdhansia XR (methylphenidate hydrochloride) extended-release capsules CII for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. Adhansia XR is a central nervous system stimulant by Adlon Therapeutics L.P.

Four clinical studies evaluated the efficacy and safety of Adhansia XR in patients with ADHD: two clinical studies in adults, one analog classroom trial in children aged 6 to 12 years, and one safety and efficacy study in children aged 12 to 17 years. Patients in all studies achieved statistically significant improvement in symptoms while receiving Adhansia XR compared with placebo.

Adhansia XR will be available in six capsule strengths: 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg. The recommended starting dose for patients 6 years and older is 25 mg once daily, with titration in increments of 10 mg to 15 mg at intervals of no less than 5 days. ■