Shire Pharmaceuticals ADHD patch approved

The first non-oral medication has been approved for the treatment of attention deficit hyperactivity disorder (ADHD) by the Food and Drug Administration of the US.

Noven Pharmaceuticals’ drug Daytrana ? licensed for distribution to Shire ? was approved following the submission of a revised New Drug Application last June.

“The approval of Daytrana is important news for ADHD patients, their families and healthcare providers,” said Matthew Emmens, chief executive officer of Shire.

“In addition to being the only patch treatment for ADHD, it offers a convenient option to deliver medicine for those diagnosed with ADHD. The addition of Daytrana to Shire’s portfolio reaffirms our position as the market leader in ADHD.”

The once daily transdermal patch, which is suitable to be worn through activities such as swimming, bathing and exercising, is available in four different dosage strengths, ranging from 10mg (of formulation of methylphenidate) to 30mg.

Two clinical trials were carried out on a number of children aged six to 11 years old, with the phase III trial that involved 270 patients demonstrating a reduction in ADHD symptoms for those wearing the patch for a nine hour period compared with placebo.

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