Shire's Daytrana patch gets FDA approval for ADHD treatment

By Elaine Rigoli

Tampa, Fla., April 6 - Shire plc announced that the Food and Drug Administration approved Daytrana (methylphenidate transdermal system), the only non-oral medication for the treatment of attention deficit hyperactivity disorder (ADHD).

Daytrana, a once daily transdermal patch formulation of methylphenidate, will be available in 10 mg, 15 mg, 20 mg and 30 mg dosage strengths, according to a news release.

Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application for Daytrana to the FDA in June 2005.

As part of the agreement between Shire and Noven for Daytrana, Shire completed an upfront payment to Noven of $25 million in 2003, and may make separate milestone payments up to $125 million; $50 million will be paid dictated by this FDA approval and $75 million conditioned upon the achievement of certain sales targets, the release said.

Daytrana is licensed globally to Shire by Noven and will be available in pharmacies in the United States in mid-2006, the release said.

The efficacy of Daytrana was established in two controlled clinical trials in children aged six to 12 years old with ADHD, the release said.

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.

Noven is a Miami, Fla.-based pharmaceutical company.

Based in Chineham, England, Shire focuses its business on central nervous system, gastrointestinal, general products and human genetic therapies.

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