BOSTON OCTOBER 25, 2007 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, announced that data from a 12-month study of DAYTRANATM (methylphenidate transdermal system), the Attention Deficit Hyperactivity Disorder (ADHD) patch, demonstrated that DAYTRANA provided significant ADHD tolerability and symptom control improvement in children aged 6 to 12 years. The study data was presented today at a major scientific and educational meeting of child and adolescent psychiatrists held in Boston, and is consistent with data previously presented.
In our study, children with ADHD experienced effective ADHD symptom control improvement when using DAYTRANA for 12 months, improving their ability to maintain focus and concentration in and outside of the classroom, reported investigator Frank A. López, M.D., neurodevelopmental pediatrician at the Childrens Developmental Center, Winter Park, Fla. Importantly, this year-long study showed that DAYTRANA maintained a favorable safety profile throughout the study period, with adverse events consistent with previous DAYTRANA studies.
Shires DAYTRANA is the first and only patch medication approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of ADHD in children aged 6 to 12 years. The study results demonstrate that adverse events associated with DAYTRANA were similar to other methylphenidate products. The most common adverse events reported in this study were decreased appetite, headache, upper respiratory tract infection, cough, fever, and decreased weight. When worn for the recommended nine hours, efficacy has been demonstrated from the first time point measured (two hours) through the 12-hour time point. Because DAYTRANA is a patch, physicians may recommend that patients shorten the wear time if shorter duration of effect is desired or to help manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping.
López added, DAYTRANAs novel patch delivery system offers physicians and parents of children with ADHD a convenient, non-oral option to individualize ADHD treatment to meet their childrens changing schedules.
While this study evaluated the safety and effectiveness of DAYTRANA for up to 12 months, DAYTRANA has not been studied versus placebo for longer than 7 weeks. Physicians, who prescribe DAYTRANA for long-term use, should periodically re-evaluate patients to assess the usefulness of DAYTRANA for the individual patient.
The study was supported by funding from Shire.