Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plcJul 7 2010

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years.  Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years.  Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

"The FDA approval of Daytrana for adolescents now extends this medication option to an additional group of ADHD patients who may benefit from ADHD treatment delivered by a patch," said Mike Yasick, senior vice president of the Shire ADHD business unit.  "This approval reinforces Shire's commitment to providing a varied and comprehensive portfolio of medicines to meet the diverse needs of ADHD patients."

The efficacy of Daytrana was demonstrated in a multi-center, 7-week, phase 3b, randomized, double-blind, placebo-controlled study in 217 adolescents aged 13 to 17 diagnosed with ADHD.  The primary efficacy measure was the mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score.  The Daytrana treatment group demonstrated significant reduction (indicating improvement) in ADHD-RS-IV total score from baseline to endpoint compared with placebo (P<.001). The most commonly reported adverse reactions associated with Daytrana (greater than or equal to 5% and twice the rate of placebo) in this study were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia (persistent loss of appetite).  The majority of subjects in the study had erythema (redness or rash) at the application site.

Daytrana is a transdermal patch that is applied to intact skin and delivers methylphenidate through the skin into the bloodstream.  It is recommended that Daytrana be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application.  The effects can continue for several hours after the patch is removed.  With guidance from the prescribing physician, Daytrana can be removed earlier than 9 hours if a shorter duration of effect is desired and/or to help manage potential late-day side effects.  This flexibility allows parents, working with physicians, to tailor the treatment to a patient's specific needs and to accommodate changing schedules.  Daytrana is available in patch strengths of 10 mg, 15 mg, 20 mg, and 30 mg (nominal dose delivered over a 9-hour wear time). The prescribing physician should titrate the dose of DAYTRANA to the desired effect.