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Quillivant XR (Methylphenidate) Launched in U.S. for Treatment of ADHD
Quillivant XR (methylphenidate hydrochloride, Pfizer) — a once-daily, extended-release liquid methylphenidate — is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD). The drug was approved by the FDA in September 2012 for the treatment of ADHD in patients aged 6 years and older.
The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover, laboratory classroom study of 45 children with ADHD. The drug significantly improved ADHD symptoms compared with placebo at the primary endpoint of 4 hours after dosing. Moreover, in a secondary analysis, significant improvement was noted at every time point measured, from 45 minutes to 12 hours post-dose.
ADHD is one of the most common neurobehavioral disorders in the U.S. According to 2007 data from the Centers for Disease Control and Prevention (CDC), about 10% of children aged 4 to 17 years in the U.S. had received a diagnosis of ADHD. Patients with ADHD may suffer from symptoms such as difficulty paying attention, impulsivity, and being overly active. The condition can last into adulthood.
Quillivant XR (methylphenidate hydrochloride) is a federally controlled substance (CII) because it can be abused or lead to dependence.
Source: Pfizer; January 14, 2013.