ADHD News & Research

New Stimulant ADHD Medication Approved By FDA

The extended-release stimulant ADHD medication, Adhansia XR (methylphenidate hydrochloride), has been approved by the FDA to treat attention deficit hyperactivity disorder in patients six years and older.

Effective July 20, 2022, Adlon Therapeutics has discontinued the sale of Adhansia XR® (methylphenidate HCI) extended-release capsules.

June 27, 2019

Adhansia XR (methylphenidate hydrochloride) is an extended-release central nervous system stimulant medication recently approved by the FDA for attention deficit disorder (ADHD or ADD) treatment in patients six years and older. The approval was based on four clinical studies evaluating Adhansia XR’s efficacy and safety to treat ADHD symptoms in adult and pediatric patients.

The new stimulant ADHD medication capsules contain multi-layered beads comprising an immediate-release (IR) layer that contains roughly 20% of the methylphenidate dose, and a controlled-release layer that disburses the remaining medication over a period up to 16 hours. Adhansia XR will come in six capsule strengths: 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg. The drug manufacturer, Adlon Therapeutics LP, recommends that prescribing clinicians start patients six years or older with a dose of 25 mg once daily and titrate from there.

Methylphenidate medications, like Adhansia XR, paired with behavioral therapies and lifestyle interventions, are the first-line ADHD treatment for most children diagnosed with attention deficit hyperactivity disorder. Andrew J. Cutler, MD, the chief medical officer of Meridian Research and an investigator on Adhansia XR clinical studies, said the new ADHD medication “offers a methylphenidate treatment option with a longer duration of efficacy, which may be appropriate for these patients.”1

Andrew J. Cutler. FDA approves Adhansia XR for ADHD. Healio Psychiatry. (Mar. 2019)