01.06.2001 | Adis New Drug Profile
Methylphenidate (OROS® Formulation)
Erschienen in: CNS Drugs | Ausgabe 6/2001
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▲ Methylphenidate is a CNS stimulant that is thought to block the reuptake of dopamine and noradrenaline (norepinephrine) into the presynaptic neuron. A sustained release (OROS®) formulation of the drug has been developed for use in children with attention deficit/hyperactivity disorder (ADHD).
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▲ In children aged 6 to 12 years with ADHD, the maximum plasma concentration of OROS® methylphenidate 18 to 54mg was reached after approximately 7 to 8 hours. In adults, the plasma concentration-time profile of OROS® methylphenidate differed markedly from that of the sustained release and immediate release (IR) methylphenidate formulations.
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▲ In a clinical trial involving 282 children with ADHD, once daily OROS® methylphenidate 18 to 54mg was significantly more effective than placebo and demonstrated an effect similar to IR methylphenidate 5 to 15mg 3 times daily in reducing the symptoms of ADHD.
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▲ OROS® methylphenidate demonstrated sustained efficacy in a 1-year noncomparative study involving children with ADHD.
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▲ In clinical trials, the OROS® formulation of methylphenidate had a tolerability profile similar to that of IR methylphenidate.