Dexmethylphenidate Extended Release: A Review of its Use in the Treatment of Attention-Deficit Hyperactivity Disorder

Moen, Marit D.; Keam, Susan J.
December 2009
CNS Drugs;2009, Vol. 23 Issue 12, p1057
Academic Journal
Dexmethylphenidate extended release (XR) [Focalin® XR] is a CNS stimulant indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged ≥6 years. Dexmethylphenidate contains the d-threo-enantiomer of methylphenidate. Dexmethylphenidate XR capsules have a bimodal release profile, which mimics two doses of dexmethylphenidate immediate release (IR) given 4 hours apart, and allows once-daily administration. Once-daily dexmethylphenidate XR was effective and generally well tolerated in the treatment of ADFID in children, adolescents and adults in placebo-controlled trials. Improvements in ADHD symptoms were significantly greater for dexmethylphenidate XR versus placebo throughout the day, from as early as 0.5 hours after drug administration up to 11-12 hours after administration. Furthermore, dexmethylphenidate XR showed greater efficacy than osmotic release oral system (OROS®) methylphenidate over the first half of the laboratory classroom day in crossover trials; however, assessments late in the day (10-12 hours post-dose) favoured OROS® methylphenidate. The once-daily administration regimen with dexmethylphenidate XR avoids the need for a midday dose to be administered at school; administration options are extended in that the contents of the dexmethylphenidate XR capsule can be sprinkled on apple sauce for patients unable to swallow the capsule whole. Although dexmethylphenidate XR is a controlled substance in the US, this formulation appears to have a low risk of abuse or misuse. Thus, dexmethylphenidate XR extends the range of first-line pharmacological treatment options for children, adolescents or adults with ADHD, particularly for patients who require a rapid onset and prolonged duration of action, including children who require a reduction in ADHD symptoms throughout the school day. Methylphenidate is thought to increase levels of dopamine and noradrenaline (norepinephrine) in the synaptic cleft in specific regions of the brain, primarily by blocking their reuptake into presynaptic neurons. However, the neurophysiology of ADHD is not fully understood. Dexmethylphenidate contains only the d-threo-enantiomer of methylphenidate, which is primarily responsible for the beneficial effects of racemic methylphenidate. The l-enantiomer appears to have negligible activity. Oral dexmethylphenidate XR capsules have a bimodal pharmacokinetic profile because each capsule contains half the dexmethylphenidate dose as immediate-release beads and half as enteric-coated, delayed-release beads. Following a single. dose of oral dexmethylphenidate XR, the first dexmethylphenidate peak plasma concentration is reached at 1.5 hours, and a second peak is reached at 6.5 hours after drug administration.…


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