ADHD symptom control demonstrated from the first time point measured (1.5 hours) through 13 hours postdose

PHILADELPHIA, June 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment VYVANSE(R) (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours postdose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13-hour postdose efficacy data for pediatric patients included in its product labeling.

'Children with ADHD who still exhibit symptoms into the evening might need a treatment that provides a long duration of effect from morning, through homework and family time,' said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. 'The FDA approval of this labeling change for VYVANSE provides important additional information for physicians on the duration of effect of VYVANSE and use as a once daily treatment option.'

This update to the VYVANSE product labeling is based on a 13-hour analog classroom study that demonstrated improvements in behavior, inattention, and math test scores in children aged 6 to 12 from the first time point measured (1.5 hours) through the last time point assessed (13 hours) postdose. This study supports the results of a previous Phase 2 laboratory school study in which VYVANSE demonstrated ADHD symptom control from the first time point assessed (two hours postdose) with duration of efficacy up to 12 hours postdose. The adverse events in the 12-hour study for patients taking VYVANSE during the double-blind treatment period, which were greater than or equal to 2 percent, were insomnia, decreased appetite, and anorexia.

VYVANSE Demonstrated Significant Efficacy Versus Placebo at 13 Hours Postdose

The study that led to this approval of revised labeling for VYVANSE was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.

The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of VYVANSE compared with placebo as measured by SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.

In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. Further, VYVANSE treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0 and 12.0 hours).

Safety was also evaluated during the study.