Shire has agreed to a written request by the US Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate the potential use of Vyvanse (lisdexamfetamine dimesylate) to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, aged four to five years.
At present there are few adequate and well-controlled studies of pharmacotherapy in preschool-age children with ADHD and the company is the process of developing design protocols for three clinical trials with Vyvanse.
The three studies include a pharmacokinetic study to help determine appropriate dosing and evaluate safety and tolerability; an efficacy and safety study; and an open-label study to evaluate long-term safety.
The company will also form a Data Monitoring Committee to monitor patient safety throughout the duration of the clinical program.
First trial in the preschool pediatric clinical trial program is expected to be started in the first half of 2015.
Shire Research and Development head Philip Vickers said the company 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," Vickers said.
Following FDA confirmation of a timely submission and review of data that adheres to the requirements of the Written Request, the company will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire’s patents for Vyvanse, which expire in 2023.