The patch formulation of the active ingredient methylphenidate will be available in 10mg, 15mg, 20mg and 30mg dosage strengths.
Daytrana is licensed globally to Shire by Noven Pharmaceuticals. The companies submitted an amended new drug application for the patch to the FDA in June of last year.
This FDA approval triggers a $50 million milestone payment from Shire to Noven, and Noven may receive an additional $75 million upon the achievement of certain sales targets.
The efficacy of Daytrana was established in two controlled clinical trials in children aged 6 to 12 years old with ADHD. Daytrana combines methylphenidate, a medication with a 50-year history of use, with Noven’s patented DOT Matrix transdermal technology.
This transdermal delivery system delivers medication directly through the skin into the bloodstream, and is designed to provide consistent, smooth drug release throughout the day.
“The FDA’s approval of Daytrana offers an important new option in the treatment of ADHD in children,” said Dr Robert Findling, lead investigator director of the Division of Adolescent and Child Psychiatry, Case Western University. “Daytrana has been shown to be effective and generally well tolerated in clinical studies, and offers ADHD treatment in the convenient form of a patch.”