FDA Approves First Liquid, Extended-Release Formulation of Methylphenidate for ADHD

The US Food and Drug Administration (FDA) has approved extended-release methylphenidate hydrochloride oral suspension for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Efficacy was determined in a 2 week randomized, double-blind, crossover study that showed improvement for both attention and behavior metrics for up to 12 hours in children aged 6 to 12 years diagnosed with ADHD compared with placebo. The once-daily treatment will be available in January 2013.

The concentration of the oral suspension is 5 mg/mL. The recommended dose for children aged 6 years and older is a starting dose of 20 mg given orally once a day, in the morning, and increasing the dose weekly by 10-20 mg per day. Exceeding a daily dosage of 60 mg is not recommended, according to the prescribing information.

The FDA, which approved the drug in late September, said it is the first liquid formulation extended-release product to treat ADHD. It is manufactured by NextWave Pharmaceuticals, and will be marketed as Quillivant XR. The company website says it will be available in pharmacies in January 2013.