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ADHD Drug Vyvanse Will Be Tested On Preschoolers
- Updated: June 12, 2014
There haven’t been any adequate drug trials or studies in preschool aged ADHD patients. However, following a request by the FDA, pharmaceutical company Shire which is based in Ireland has agreed to test their ADHD drug Vyvanse in preschoolers aged four to five. The US regulatory body FDA says the drug should be prescribed to patients who are aged six years or more.
Vyvanse sales increased nearly 19% last year. It has been approved for ADHD treatment in many countries including USA, Canada, Australia, Mexico, Brazil etc. “Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients,” said Philip Vickers, head of R&D at Shire. “Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD,”
Shire is now developing protocols for three trials with the drug that will make up the pediatric clinical trial program in the preschool children. The aim of the trials is to help determine appropriate dosage and evaluate the safety and tolerability of the drug in this age group. The three studies that will be carried out are a pharmacokinetic study, an efficacy and safety study and an open label study to evaluate long term safety.
Shire expects that the first phase of the trial program should start in the first half of 2015. If Shire submits the data as requested by the FDA in a timely fashion, then Shire will receive 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.