May 04, 2010
Vyvanse label updated to include supplemental efficacy data in adultsThe FDA has approved a change to the prescribing information for Vyvanse (lisdexamfetamine dimesylate capsules, from Shire). The updated labeling now includes supplemental data demonstrating statistically significant improvement in attention in adults with attention deficit hyperactivity disorder (ADHD) across all six assessments conducted at two, four, eight, 10, 12 and 14 hours after administration as measured by average Permanent Product Measure of Performance (PERMP) total scores, as well as at each time point measured.
Additionally, patients treated with Vyvanse demonstrated an approximate 52% reduction from baseline in average ADHD Rating Scale (AHDH-RS) total scores versus an approximate 21% compared to patients treated with placebo. The data support the results of a previous Phase 3 clinical study of adults with ADHD in which Vyvanse significantly improved the ADHD symptoms of inattention, as well as of hyperactivity and impulsivity, as measured by the ADHD-RS-IV with adult prompts.
Vyvanse is indicated for the treatment of attention deficit hyperactivity disorder in children and adult patients.
For more information call (800) 828-2088 or visit www.vyvanseadult.com.