Shire's Daytrana transdermal system for ADHD well tolerated in clinical trials

By Lisa Kerner

Erie, Pa., May 24 - Shire plc said its methylphenidate transdermal system, Daytrana, demonstrated statistically significant reductions in the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12 years in four analyses of two clinical trials reported at a medical meeting in Toronto.

Daytrana, a patch, is approved by the Food and Drug Administration for once-daily use to treat ADHD in children aged 6 to 12 years and is expected to be available in pharmacies in mid 2006, according to a company news release.

The patch, in four dosage strengths (10 mg, 15 mg, 20 mg and 30 mg), is designed for nine-hour wear times with 12-hour efficacy.

In the phase 2 analog classroom study of 79 children with ADHD, improvement was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham-Deportment (Skamp-D) scale. Participants using Daytrana reduced their Skamp-D scores to an average of 3.2 points compared to an average score of 8.0 points for those on placebo from baseline.

The Daytrana group also reduced their average total scores on two secondary measures from baseline, the Skamp-attention subscale and Skamp total subscale, to 6.2 and 9.4, respectively, compared to placebo (9.9 and 17.9).

An additional analysis of the classroom study data showed that overall average total scores on the standard Conners' Parent Rating Scale-Revised: Short Form were also lower compared to those on placebo.

In a phase 3 study, 270 participants were randomly placed in one of three treatment groups: a Daytrana patch and a placebo capsule, a placebo patch and an oral extended-release methylphenidate capsule or a placebo patch and placebo capsule.

In this study, the Daytrana patch reduced the children's overall symptoms of ADHD, compared to a placebo, as measured by the ADHD Rating Scale-IV (ADHD-RS-IV).

Additional analysis in this study revealed that total scores on the standard Conners' Teacher Rating Scale-Revised: Short Form were also reduced for those using the patch, compared to placebo.

Shire is a Philadelphia-based specialty pharmaceutical company.

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