An extended-release liquid formulation of methylphenidate, taken once a day, has been approved by the Food and Drug Administration for treating attention-deficit/hyperactivity disorder.
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.
Efficacy for the product was established in a 2-week, placebo-controlled crossover study of children who diagnosed with ADHD, aged 6-12 years, in a laboratory classroom, 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.