Shire To Initiate Two Phase 4 Clinical Trials To Compare Vyvanse® (lisdexamfetamine Dimesylate) Capsules, (CII) To Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
Shire recently completed a Phase 3, 8-week double blind, dose-optimized, placebo-controlled study of Vyvanse in the treatment of ADHD in children and adolescents in which Concerta was an active reference arm. Formal comparisons between Vyvanse and Concerta were not planned as part of that study. However, the data do suggest this as an area for further investigation. The data from this study have been presented previously at a major psychiatry meeting in late 2011.
"It is important for practicing physicians to have access to information on comparative efficacy of different approved medications when developing a personalized treatment approach for individuals with ADHD," said Jeffrey Newcorn, MD, Associate Professor of Psychiatry and Pediatrics, Mount Sinai School of Medicine. "I expect the data from these studies may aid prescribers in making individualized treatment decisions for their adolescent patients with ADHD."
Vyvanse should be used as part of a total treatment program that may include counseling or other therapies. The physician who elects to use Vyvanse for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Concerta ® is a registered trademark of ALZA Corporation.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, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. Additional information about Vyvanse is available at http://www.vyvanse.com. INDICATION Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above as part of a total treatment plan that may include other measures (psychological, educational, social). Efficacy was established in short-term controlled studies in children aged 6 to 17 and adults. Vyvanse is also approved as a maintenance treatment for adults with ADHD based on one randomized withdrawal study. Extended use of Vyvanse should be periodically reevaluated to determine its long-term usefulness for the individual patient.
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