FDA Requests Clinical Trials to Investigate Use of Lisdexamfetamine (Vyvanse) in Preschool-Age Children With ADHD
Studies to begin in first half of 2015
Shire Pharmaceuticals has agreed to a written request from the FDA to conduct pediatric clinical studies investigating the potential use of lisdexamfetamine dimesylate (Vyvanse) capsules (CII) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in preschool-age children (4 to 5 years of age).
In the U.S., Vyvanse is approved for the treatment of ADHD in patients aged 6 years and older.
Few adequate and well-controlled studies of pharmacotherapy have been conducted in preschool-age children with ADHD. Design protocols are being developed for three clinical studies of lisdexamfetamine that will make up the FDA-requested clinical trial program in preschool children: a pharmacokinetic study to help determine appropriate dosing and to 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.
The first trial in the preschool pediatric clinical trial program is expected to begin in the first half of 2015.
Upon FDA confirmation of a timely submission and review of data that adhere to the requirements of the written request, Shire will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a 6-month extension to the exclusivity afforded by Shire’s patents for Vyvanse, which expire in 2023.
Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are noncatecholamine sympathomimetic amines with central nervous system stimulant activity. Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The parent drug, lisdexamfetamine, does not bind to the sites responsible for the reuptake of norepinephrine and dopamine in vitro.
The labeling for Vyvanse (lisdexamfetamine dimesylate) includes a boxed warning regarding the high potential for abuse and dependence associated with CNS stimulants.