Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents...(us needs of patients diagnosed with ADHD...),Health

Date:10/30/2009

us needs of patients diagnosed with ADHD. Once-daily Daytrana is a transdermal alternative to oral immediate- and extended-release formulations of methylphenidate, an active ingredient that has been used to treat ADHD for over 50 years," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "The short term efficacy and safety profile of Daytrana in adolescents has been previously reported and this Shire-supported study examined the tolerability and effectiveness of the medication in the adolescent population over an extended period of six months."

Long-Term Open-Label Tolerability and Effectiveness Study in Adolescents with ADHD

In this study, Daytrana participants were titrated to their optimal dose over five weeks and were then maintained on that dose for an additional five months. Participants from a previous double-blind, seven week study were able to enroll. In this seven week study, Daytrana was shown to significantly improve ADHD symptoms as rated by clinicians and parents compared with placebo. The frequency of adverse events was typical of these seen in studies of oral methylphenidate in adolescents, with the exception of dermal reactions. The long term extension study evaluated four doses of the Daytrana patch worn for nine hours at alternating hips and used for about six months. Most adverse events were mild to moderate in intensity. The most commonly reported treatment-emergent adverse events reported by 5 percent or more of participants that received Daytrana were decreased appetite (11.0 percent); headache (10.1 percent); upper respiratory tract infection (10.1 percent); nasopharyngitis (inflammation of the nasal passages and of the upper part of the pharynx) (9.2 percent); and irritability (5.5 percent). The majority (93.6 percent) of skin response scores were defined as no irritation or minimal to definite redness.

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