New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for...(and finish tasks) while boys tend to exh...),Health

Date:5/7/2008

and finish tasks), while boys tend to exhibit disruptive symptoms such as hyperactivity and impulsivity (e.g., restlessness, interrupting, impulsive decisions). In children, ADHD may interfere with paying attention in school, completing homework or making friends. Difficulties experienced by these children may continue into adulthood.

Summary of Analysis Findings

This analysis was conducted using data from an open-label, flexible dose, 12-month extension study in which 326 children received DAYTRANA. Children who enrolled in this study previously participated in other studies in which they received DAYTRANA, osmotic-release oral system (OROS) methylphenidate or placebo as part of the study design. The primary objective of this study was to investigate the long term safety profile of ADHD treatment with DAYTRANA, and the secondary objective examined the efficacy of the medication between genders. This subanalysis was conducted to examine treatment differences between boys and girls receiving DAYTRANA.

Adverse events were reported in a higher percentage of boys than girls in all dose groups; however, they were generally comparable between genders. Further, no clinically significant differences in adverse events were noted between boys and girls. Adverse events were typically mild or moderate and consistent with stimulant treatment. The most common adverse events included decreased appetite, headache, upper respiratory tract infection, cough, fever and decreased weight.

In the study, the efficacy of DAYTRANA was measured using the ADHD Rating Scale (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale and the Parent Global Assessment (PGA) rating scale and measurement results were found to be statistically significant on all scales. In the analysis, boys had a 41 percent change on the ADHD-RS-IV (as calculated from a mean baseline score of 11.6, with a mean change from baseline to endpoint of -4.8) and girls had a 23 percen
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