FDA Approves Agent for Maintenance Therapy in Adult ADHD

Caroline Cassels

Disclosures

February 08, 2012

February 8, 2012 — The US Food and Drug Administration has approved the stimulant medication lisdexamfetamine dimesylate (Vyvanse, Shire) as maintenance therapy for adults with attention deficit hyperactivity disorder (ADHD).

According to a press release issued by the drug's manufacturer, the approval is based on results from a randomized withdrawal study designed to evaluate the efficacy of the drug in 123 adults aged 18 to 55 years who were receiving treatment with Vyvanse for a minimum of 6 months before enrolling in the study and who were responsive to the drug.

The company reports that 8.9% of patients in the active treatment group experienced a relapse of symptoms compared with 75% (P < .0001) of those in the placebo group during the 6-week double-blind withdrawal phase of the study.

The majority of patients in the placebo group (62%) who met criteria for relapse as measured by the ADHD Rating Scale IV (ADHD-RS-IV) did so within 2 weeks of the withdrawal phase.

"The finding from this study is important because adult patients with ADHD may have a need for extended treatment, and could benefit from a treatment option proven to maintain efficacy," principal investigator Matthew Brams, MD, said in a statement issued by Shire.

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