Shire announces Phase IIIb study results of Daytrana

Oct 31 2009

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). In addition, data regarding the pharmacokinetic profile of Daytrana in children and adolescents was also presented. Daytrana, the first and only patch for the treatment of ADHD, is indicated for use in children aged 6 to 12 years with the disorder.

Alain Katic, MD, child psychiatrist at the Claghorn Research Clinic in Houston, Texas, states, "In this 6-month, open-label adolescent extension study, we found that most adverse events were generally mild to moderate in intensity. Additionally, Daytrana treatment resulted in significant improvements in ADHD Rating Scale IV mean total scores from baseline to end point."

Daytrana delivers medication directly through the skin into the bloodstream and is designed to release methylphenidate continuously while applied to the skin. Daytrana is approved by the US Food and Drug Administration (FDA) for a wear-time of nine hours; however, the patch can be removed earlier to accommodate changing schedules or to help manage late day side effects, allowing parents, working with physicians, to tailor the treatment to a child's specific needs. Daytrana is available in 10-mg, 15-mg, 20-mg, and 30-mg patches.

"As a leader in ADHD treatment, Shire is proud to offer treatment options to help meet the various 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."

SOURCE Shire plc