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news.The Health Canada has given approval to Shire for its treatment of attention deficit hyperactivity disorder (ADHD) in adolescents and adults, Vyvanse (lisdexamfetamine dimesylate capsules).
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Shire claims that Vyvanse is the first and only once-daily prodrug stimulant approved to treat ADHD in adolescents and adults.
The FDA’s approval of Vyvanse in adolescents and adults was based on the results of two pivotal clinical studies (one in adolescents aged 13 to 17, and one in adults).
In an additional randomized, double-blind placebo-controlled clinical study in adults in a simulated workplace environment, efficacy was measured using the PERMP (math problems) score at 2, 4, 8, 10, 12 and 14 hours post-dose.