Vyvanse (lisdexamfetamine dimesylate) Capsules, Now Approved in the US for Maintenance Treatment in Adults with ADHD

Shire plc

today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules, (

) as a maintenance treatment for adults with ADHD. The approval is based on results from a randomized withdrawal study designed to evaluate the efficacy of Vyvanse in adults (aged 18 to 55 years) who were receiving treatment with Vyvanse for a minimum of 6 months prior to enrolling in the study. Significantly more patients treated with Vyvanse maintained ADHD symptom control compared with placebo 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). This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients ages 6 and above. 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.