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FDA requests ADHD drug studies include preschool-aged children

In response to an FDA request, Shire will conduct clinical studies of lisdexamfetamine dimesylate for the treatment of attention-deficit/hyperactivity disorder among children aged 4 to 5 years, according to a press release from the drug manufacturer.

Shire is developing three clinical trials to determine dosing and assess safety and tolerability, evaluate efficacy, and investigate long-term safety of the use of lisdexamfetamine dimesylate (Vyvanse) among preschool-aged children. The drug is currently indicated for children aged 6 years and older.

The first trial is anticipated to begin in 2015, according to the release. Upon FDA confirmation of submission and data review, Shire will benefit from the Best Pharmaceuticals for Children Act, which includes a 6-month extension to the manufacturer’s patents for lisdexamfetamine dimesylate, which expires in 2023.

“Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients. Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-aged children with ADHD,” Philip Vickers, PhD, head of research and development at Shire, said in the release.