Patients receiving Vyvanse demonstrated a moderate increase in mean pulse rate (~5 beats per minute) and blood pressure (~2 mm Hg systolic and diastolic blood pressure) between baseline and end point of the randomized withdrawal period. Patients treated with Vyvanse experienced a mean decrease in body weight of about 2 kg during the 26-week open-label period. Mean weight tended to increase in patients who switched to placebo during the randomized withdrawal phase. There were no deaths reported during the trial. The safety profile seen in this study was consistent with that of other studies of Vyvanse, and no new clinically relevant safety signals were associated with abrupt discontinuation of Vyvanse.
"This study is evidence of Shire's commitment to conducting research in ADHD and contributing to the body of knowledge about treatment options," said Arnaud Partiot, M.D., Ph.D., senior vice president and head of Research and Development for Shire. "Vyvanse is now the only stimulant approved for maintenance treatment in patients ages 6 and above."
ABOUT VYVANSE (lisdexamfetamine dimesylate)
Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, approved in November 2010 to treat ADHD in adolescents ages 13 to 17, approved in January 2012 for maintenance treatment in adults, and approved in April 2013 for maintenance treatment in children and adolescents, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.Vyvanse may be used as part of a total treatment program that may include counseling or other therapies. Additional information about Vyvanse is available at http://www.vyvanse.com. INDICATION