Shire plc hasannounced that the FDA has approved a changeto the prescribing information for its once-daily Attention DeficitHyperactivity Disorder (ADHD) treatment VYVANSE(R) (lisdexamfetaminedimesylate) CII, to include supplemental data that demonstrated significantADHD symptom control in children aged 6 to 12 from the first time pointmeasured (1.5 hours) through 13 hours postdose. VYVANSE is now the first andonly oral ADHD stimulant treatment to have 13-hour postdose efficacy data forpediatric patients included in its product labeling. “Children with ADHD who still exhibit symptoms into the evening might needa treatment that provides a long duration of effect from morning, throughhomework and family time,” said Michael Yasick, Senior Vice President of theADHD Business Unit at Shire. “The FDA approval of this labeling change forVYVANSE provides important additional information for physicians on theduration 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 analogclassroom study that demonstrated improvements in behavior, inattention, andmath 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. Thisstudy supports the results of a previous Phase 2 laboratory school study inwhich VYVANSE demonstrated ADHD symptom control from the first time pointassessed (two hours postdose) with duration of efficacy up to 12 hourspostdose. The adverse events in the 12-hour study for patients taking VYVANSEduring the double-blind treatment period, which were greater than or equal to2 percent, were insomnia, decreased appetite, and anorexia.
