ADHD Skin Patch Gets Approved

The Food and Drug Administration approved the first skin patch treatment for attention deficit hyperactivity disorder, giving the go-ahead Thursday for Daytrana from Noven Pharmaceuticals (NOVN) and Shire (SHPGY).

The skin patch contains methylphenidate, the same ingredient found in Ritalin, another ADHD drug made by Novartis (NVS) and by several generic-drug companies. Daytrana was approved for children age 6 to 12.

Shire has designs on becoming the dominant player in ADHD drugs. The company already makes and sells Adderall and Adderall XR, which can be prescribed for adults, teenagers and children. Additionally, Shire is working with New River Pharmaceuticals (NRPH) of Radford, Va., on an ADHD drug that's being reviewed by the FDA as a treatment for children 6 to 12 years old.

The FDA announcement came after the markets closed Thursday. On Friday, Miami-based Noven saw its shares add 12 cents, or 0.7%, to $17.92. Shire, of Basingstoke, England, was up 10 cents, or 0.2%, to $46.35.

In December, the FDA issued conditional approval for Daytrana, telling Noven and Shire that it had questions about the proposed label. The agency also wanted a clarification of certain data and information about post-marketing surveillance and studies.

Since then, two FDA advisory committees have met to discuss the potential side effects of existing ADHD drugs. One committee voted 8-7, with one abstention, in February that the FDA require a black box warning on all stimulant drugs, including the Adderall family and Ritalin, about their cardiovascular risks.

The black box warning is the agency's strongest alert for side effects. The FDA hasn't acted on the recommendation. Adderall and Adderall XR have a black box warning saying that amphetamine abuse can lead to heart damage or sudden death.

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