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news.Shire, a global specialty biopharmaceutical company, has received FDA approval for Daytrana (methylphenidate transdermal system) to treat attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.
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Shire said that Daytrana, a transdermal patch that is applied to intact skin, delivers methylphenidate through the skin into the bloodstream.
Daytrana showed reduction in ADHD-RS-IV total score from baseline to endpoint compared with placebo in a a multi-center, 7-week, Phase 3b, randomised, double-blind, placebo-controlled study in 217 adolescents aged 13 to 17 diagnosed in ADHD patients.
In market, Daytrana is already available in patch strengths of 10mg, 15mg, 20mg, and 30mg (nominal dose delivered over a 9-hour wear time).
Mike Yasick, senior vice president of ADHD business unit at Shire, said: “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.
“This approval reinforces Shire’s commitment to providing a varied and comprehensive portfolio of medicines to meet the diverse needs of ADHD patients.”