FDA Approves Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults
The drug is Shire’s top-selling pharmaceutical, achieving sales of $199.7 million in the three months to September 30 2011, up 32% on the same period in 2010.
The US FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance therapy for adult patients with attention-deficit/hyperactivity disorder (ADHD).
Approval was based on data from a Phase IV placebo-controlled withdrawal design study in 123 adult patients who met DSM-IV-TR criteria for ADHD.
"Vyvanse is the first medicine both proven to work and approved to maintain efficacy in adults with ADHD,” comments Jeffrey Jonas, M.D., svp for R&D at Shire’s specialty pharmaceuticals and regenerative medicines businesses.
Vyvanse was introduced in the U.S. in 2007 for the treatment of ADHD in children aged 6–12 years, and
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