Shire, Noven says FDA advisory committee gave Daytrana patch for ADHD a thumb's up

By E. Janene Geiss

Philadelphia, Dec. 2 - Shire plc and Noven Pharmaceuticals, Inc. said Friday that a psychopharmacologic drugs advisory committee recommended to the U.S. Food and Drug Administration that Daytrana (methylphenidate transdermal system) is safe and effective.

Daytrana is an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years, according company news releases.

Shire and Noven submitted an amended New Drug Application for Daytrana to the FDA in June of this year.

At the request of the FDA, a meeting with the advisory committee was held Friday to review the safety and effectiveness of the drug.

The FDA asked the committee to vote on whether the product has been shown to be effective for the treatment of ADHD and whether the product has been shown to be acceptably safe in the treatment of ADHD.

On the first question, the committee voted unanimously in favor of the product's efficacy, officials said.

On the second question, the committee voted unanimously in favor of the product's safety, but recommended that the FDA require post-marketing surveillance and/or studies related to the product, officials said.

The committee also recommended to the FDA that consideration of oral ADHD products be given prior to use of the product, but rejected a proposal by a vote of 11 to one to limit use of the product to patients who cannot use oral methylphenidate products.

"We are pleased that the advisory committee voted in favor of Daytrana's safety and efficacy in children diagnosed with ADHD," Shire chief executive officer Matt Emmens said in the release. "This delivery option can provide a much needed alternative for parents and physicians to help children living with ADHD."

An FDA decision is scheduled to be announced on or before Dec. 28, 2005. The recommendation of the advisory committee is not binding on the FDA.

Noven, based in Miami, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products.

Shire is a Basingstoke, England specialty pharmaceutical company that focuses on central nervous system, gastrointestinal, general products and human genetic therapies.

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