Date: 2014-06-12
Type of information: Initiation of development program
phase: pediatric study
Announcement: initiation of a new pediatric development program
Company: Shire (UK-USA)
Product: Vyvanse® (lisdexamfetamine dimesylate)
Action
mechanism: CNS stimulant. Lisdexamfetamine dimesylate is a chemically formulated long-acting, prodrug of dextroamphetamine, that belongs to the group of central nervous system stimulants. Amphetamines target the trace amine-associated receptor 1 (TAAR1). Amphetamine is also believed to exert its effects by binding to the monoamine transporters (the dopamine transporter or DAT) and increasing extracellular levels of the biogenic amines dopamine, norepinephrine (noradrenaline) and serotonin.
Disease: Attention-Deficit Hyperactivity Disorder (ADHD)
Therapeutic area: Mental diseases - CNS diseases
Country: USA
Trial details:
Latest
news: * On June 12, 2014, Shire announced that it has agreed to a Written Request by the FDA to conduct pediatric clinical studies to investigate the potential use of Vyvanse® (lisdexamfetamine dimesylate) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, ages 4 to 5. Shire is in the process of developing design protocols for three clinical trials with Vyvanse that will make up the clinical trial program in preschool children: 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. A Data Monitoring Committee will also be established to monitor patient safety throughout the duration of the clinical program. Shire anticipates beginning the first trial in the preschool pediatric clinical trial program in the first half of 2015.
Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the Written Request, Shire 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.
