Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents...(iveness measure was the change from base...),Health

Date:10/30/2009

iveness measure was the change from baseline to end point of the total mean ADHD Rating Scale IV (ADHD-RS-IV) score. The baseline was defined as the baseline from the previous double-blind study and the end point was defined as the last assessment for which a valid ADHD-RS-IV score was obtained. The ADHD-RS-IV scale contains 18 items and is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association.

Daytrana demonstrated significant improvement in the overall mean ( +/-SD) change in ADHD-RS-IV total score from antecedent study baseline to end point of this study of -23.0 ( +/-10.77) P<.001. In addition, the average ADHD-RS-IV mean total scores decreased from this study start to end from 19.8 to 13.8 (P<.001).

Pharmacokinetic Study in Children and Adolescents with ADHD

The pharmacokinetic profile of Daytrana has been previously reported for children aged 6 to 12 years; the data presented today are the first to report Daytrana pharmacokinetics that also included an adolescent population aged 13 to 17 years.

In this one-month, open-label, multiple-phase study, investigators randomized 35 children and 36 adolescents who received either Daytrana (single, multiple fixed, and multiple escalating doses, each worn for nine hours), or OROS MPH. The study's four phases were single dosing, multiple fixed dosing, dose escalation, and follow-up.

Following single and multiple fixed or escalating doses, systemic exposure was greater in children compared with adolescents, and was consistent with their lower body weights. As a result of accumulation, systemic exposure to d-MPH in children after multiple escalating doses was 1.4- to 1.6-fold higher for Daytrana compared with OROS MPH, but in adolescents was similar for the two formulations. '/>"/>

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