Shire announced that the FDA has approved Vyvanse (lisdexamfetamine dimesylate capsules) as a maintenance treatment for adults with attention deficit hyperactivity disorder (ADHD). This approval was based on data from a Phase 4, double-blind, multi-center, placebo-controlled, randomized withdrawal study designed to evaluate the efficacy of Vyvanse in adults (aged 18–55 years) who were receiving treatment with Vyvanse for a minimum of six months prior to enrolling in the study.

Significantly more patients treated with Vyvanse maintained ADHD-symptom control as determined by the proportion of patients who met criteria for relapse of symptoms at end point during the six-week randomized, double-blind withdrawal phase of the study (8.9% of Vyvanse-treated patients vs. 75% for placebo; P<0.0001).

Vyvanse, a scheduled CII controlled substance, is already indicated for the short-term treatment of ADHD in children ≥6 years and adults.

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