Shire gets approval for “first and only” ADHD patch

Shire, the British pharmaceutical company, has announced it has received approval from the FDA for Daytrana, a treatment for attention deficit hyperactivity disorder (ADHD).

Described as the “first and only” transdermal medication for ADHD, Daytrana is administered in the form of a skin patch and is available in four different doses. It is designed to administer methylphenidate continuously throughout the day. Additionally, the patch form allows doctors to tailor their own treatment regime since the patch can be easily removed to vary the effect of the medication.

In a phase III trial involving 270 patients, Daytrana was worn for nine hours and subjects displayed a 56 per cent reduction in ADHD symptoms, in comparison with 24 per cent for the placebo, according to the ADHD rating scale.

Matthew Emmens, Shire’s chief executive officer, remarked: “The availability of Daytrana, the first and only patch for ADHD, provides physicians and parents with a new, practical way to individualise treatment.”

“Daytrana is a welcome new therapy for patients and Shire is pleased to offer this latest addition to our portfolio, reinforcing Shire as the market leader in ADHD,” he added.

The drug uses Noven Pharmaceuticals’ DOT Matrix patch technology to administer methylphenidate, a drug also marketed under the brand name Ritalin. Shire paid Noven $25 million (13.65 million pounds) for Daytrana, a fee which could increase to $125 million on the achievement of certain milestones.

According to the ADHD UK Alliance, ADHD affects several per cent of schoolchildren and is more common among boys. The alliance points to studies showing a “very strong” genetic link with the disorder, while intolerance to certain foods, maternal alcoholism and heavy smoking may also have some effect.

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