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Long-term treatment with VYVANSE, first prodrug stimulant, demonstrates significant efficacy in ADHD

ch improved" by physicians on the Clinical Global Impressions-Improvement (CGI-I) scale, a secondary endpoint.

All 272 patients in the long-term trial previously participated in either of two double-blind clinical trials of VYVANSE. In the long-term trial, investigators provided participants with 30 mg once-daily doses of VYVANSE for one week, and then adjusted the dosage by 20 mg at weekly intervals during three subsequent visits to achieve optimal efficacy and tolerability. Participants continued treatment for the remaining 11 months. The maximum daily dose was 70 mg.

Safety was also evaluated during the study and VYVANSE was generally well tolerated. Most treatment-associated adverse events were mild to moderate in severity, occurred during the first eight weeks of treatment and incidence decreased over time. The most frequently reported adverse events in this trial were decreased appetite, headache, decreased weight and insomnia.

VYVANSE Demonstrated Consistent Time to Maximum Concentration of d-amphetamine from Patient to Patient

A once-daily 70 mg dose of VYVANSE provided low variability in the time from administration to maximum concentration of d-amphetamine from patient to patient. This finding was based on data from 17 children with ADHD aged 6 to 12 years enrolled in a double-blind phase II crossover trial examining the efficacy and safety of VYVANSE and mixed amphetamine salts extended release (MAS XR) in comparison to placebo.

Patients taking VYVANSE achieved maximum d-amphetamine concentration within a narrow time window of 4.5 to 6 hours. Patients taking MAS XR achieved maximum d-amphetamine concentration between 3 to 12 hours.


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Contact: Marion E. Glick
212-601-8273
Porter Novelli
23-May-2007


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