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news.The US Food and Drug Administration (FDA) has cleared Shire's prescription medication Vyvanse (lisdexamfetamine dimesylate) capsules, (CII) as a treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
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The approval is backed by results from a randomized withdrawal study designed to assess the efficacy of Vyvanse in adults aged 18 to 55 years who were receiving treatment with Vyvanse for a minimum of 6 months.
The study showed that 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.
Principal investigator of the study Matthew Brams said the study showed that in patients with ADHD who were stable on Vyvanse for 6 months, 91% randomized to receive Vyvanse continued to maintain symptom control compared with 25% taking placebo.
The FDA approval marks the use of Vyvanse as a treatment for ADHD in patients aged 6 and above.
Shire Specialty Pharmaceuticals Research and Development senior vice president Jeffrey Jonas said data from this study and the resulting approval underlines that Vyvanse can help adults with ADHD maintain symptom control.