The FDA has approved Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD, according to Shire Pharmaceuticals, a global specialty biopharmaceutical company.
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-treated, 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 versus 75% for placebo).
"Data from this study and the resulting approval illustrate that Vyvanse can help adults with ADHD maintain symptom control. Vyvanse is the first medicine both proven to work and approved to maintain efficacy in adults with ADHD" said Jeffrey Jonas, M.D., senior vice president of R&D, Shire.
This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients ages 6 and older.