FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of ADHD in adolescents aged 13 to 17 years.
FDA has approved lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.
The approval is based on study data demonstrating that compared to placebo, Vyvanse improved ADHD symptoms in adolescents with ADHD. Vyvanse also is indicated for the treatment of ADHD in children aged 6 to 12 years, and adults.
“This approval is an important addition to the armamentarium for the treatment of ADHD in adolescents,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas and adjunct assistant professor, University of Nevada School of Medicine, told Formulary. “Patients and their caregivers will be pleased to be able to obtain insurance coverage for Vyvanse if they were started on it as preteens.”
FDA’s approval of Vyvanse in adolescents was based on results from a randomized, double-blind, placebo-controlled, 4-week, forced-dose escalation study of adolescents who received 1 of 3 Vyvanse doses (30 mg/day, 50 mg/day, or 70 mg/day) or a placebo.
This study was conducted with 314 adolescents aged 13 to 17 who met DSM-IV-TR criteria for ADHD. In this study, patients were randomly assigned to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day, or 70 mg/day) or placebo for a total of 4 weeks of treatment. All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50-mg and 70-mg dose groups were escalated by 20 mg per week until they achieved their assigned dose. The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS). The ADHD-RS-IV rating scale is a measure of the core symptoms of ADHD. The core symptoms of ADHD are inattention, hyperactivity, and impulsivity. All Vyvanse dose groups were superior to placebo in the primary efficacy outcome.
The safety of Vyvanse was also evaluated during the study. The most frequently occurring treatment-emergent adverse events (≥5% and twice placebo) reported in patients treated with Vyvanse were decreased appetite, insomnia, and weight decrease. Safety results were generally consistent with previous Vyvanse studies in children and adults.