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Pharmacotherapeutic group: centrally acting sympathomimetics: ATC code: N06BA04 Mechanism of action Methylphenidate HCl is a mild central nervous system (CNS) stimulant.‍‍‍‍‍‍​​​‍​​​​​​ The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space. Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Clinical efficacy and safety Children In the pivotal clinical studies, Methylphenidate was assessed in 321 paediatric patients already stabilised with immediate release preparations (IR) of methylphenidate and in 95 paediatric patients not previously treated with IR preparations of methylphenidate. Clinical studies in paediatric patients showed that the effects of Methylphenidate were maintained until 12 hours after dosing when the product was taken once daily in the morning. Adults Short-term efficacy has been demonstrated for Methylphenidate in a dosage range of 18 to 72 mg/day. One thousand five hundred and twenty-three (1523) adults with ADHD aged 18 to 65 years were evaluated in five double-blind, placebo-controlled studies of 5 to 13 weeks duration. Methylphenidate was evaluated in 2 fixed-dose studies and 3 flexible dose studies, using DSM-IV based instruments for the assessment of ADHD symptom severity in adults. In two fixed-dose studies, Conner's Adult ADHD Rating Scales (CAARS) showed that total scores of ADHD symptoms decreased, indicating an improvement in the severity of ADHD symptoms, from baseline to double-blind end point. In one fixed-dose study, all dose levels of Methylphenidate showed clinically significantly greater symptom control (p<0.05 for all dose levels), compared to placebo as measured by a reduction in CAARS total score. In the second fixed-dose study, Methylphenidate 72 mg/day but not Methylphenidate 54 mg/day, proved to be statistically significant over placebo in reducing the CAARS ADHD symptoms total score from baseline to double-blind end point among adult subjects with ADHD (p-value 0.0024). In two flexible dose studies, the LS mean changes from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at endpoint were statistically significant (Study 1: p=0.012; Study 2: p<0.001) for final Methylphenidate dose treatment over placebo (Study 1: -10.6 for Methylphenidate vs –6.8 placebo; Study 2: -16.9 for Methylphenidate vs -12.0 for placebo ). In the third flexible dose study (Study 3), Methylphenidate showed clinically significantly greater symptom control (p<0.0001) compared to placebo as measured by a reduction in CAARS total score. The LS mean change from baseline to Final Visit (Week 8) in the total ADHD Symptoms Scores of CAARS-O:SV was -10.9 in the Methylphenidate group and -6.9 in the placebo group (based on the ITT population). In flexible dose Study 2, the magnitude of improvement in the total AISRS scores was statistically significantly larger in the Methylphenidate group than in the placebo group (p=0.0037). The LS mean (95% CI) difference from placebo was -5.3 (-8.9, -1.7). In flexible dose Study 3, the magnitude of improvement in the CAARS-O:SV scores was statistically significantly larger in the Methylphenidate group than in the placebo group (p=0.0063). The LS mean (95% CI) difference from placebo was -3.9 (-6.6, -1.1). Adults treated with Methylphenidate in four long-term open-label studies over 6 to 12 months showed improvement in all efficacy endpoints evaluated, indicating stable effects over time on the reduction in ADHD symptoms. In one open-label study in a community setting, Methylphenidate treatment for up to 9 months showed improvement from baseline values in mean global assessment of efficacy scores by both the patient and the investigator. In a second study, in which adults with ADHD received Methylphenidate for up to 1 year with a mean final dose of 67.4 mg/day showed clinically meaningful improvements from baseline in AISRS total scores with a mean change of -18.7 at the final visit. In a third long-term study of 48 weeks, adults with ADHD received Methylphenidate with a mean final dose of 46.6 mg/day showed a change from baseline in the mean DSM-IV Total ADHD symptoms score of CAARS by -17.2 at endpoint. In the fourth study, Methylphenidate was evaluated in a 52-week open label study in subjects who had previously completed a short-term placebo-controlled trial and short-term open-label extension. Adults with ADHD received Methylphenidate with a mean final dose of 53.8 mg/day showed stable effects over time on reductions in ADHD symptoms. Investigator-rated CAARS improved throughout the open-label phase, and was lower at endpoint (mean decrease by 1.9 from baseline).