Shire Agrees To FDA Request For ADHD Trial In Children

Shire announced that it has agreed to conduct pediatric clinical trials to investigate Vyvanse (lisdexamfetamine dimesylate) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children (4 to 5 years old) in accordance to a Written Request by the Food and Drug Administration (FDA).

Vyvanse (lisdexamfetamine dimesylate) is a prescription medicine currently approved only for the treatment of ADHD in patients 6 years old and above in the U.S., Australia, Canada, Mexico and a number of European countries. Lisdexamfetamine dimesylate is a federally controlled substance because patients could abuse the drug or become dependent on it.

Philip Vickers, Head of Research and Development at Shire, said, “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-age children with ADHD.”

Attention-Deficit/Hyperactivity Disorder is a neurobehavioral disorder characterized by regular inattention, hyperactivity, or impulsivity that hinders normal function and development. An estimated 3 to 5 percent of the preschool population is affected by the disorder, with data suggesting that only a small percentage responds adequately to behavioral therapy.

Few adequate and well-controlled studies of pharmacotherapy exist in preschool-age children with ADHD. The company said it is designing protocols for three clinical trials for Vyvanse. One of these is a pharmacokinetic study to identify the appropriate dosage and to assess the drug’s safety and tolerability, while another is an efficacy and safety study. The last one will be an open-label study to determine the drug’s long-term safety.

Once the FDA confirms timely submission and data review in accordance to the Written Request, the company will be entitled to several benefits under the Best Pharmaceuticals for Children Act. These include a six-month extension of exclusivity among others.

Shire said it expects to begin the first trial of Vyvanse for preschool pediatric patients in the first half of 2015.