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EU Study Shows Once-Daily Lisdexamfetamine Dimesylate (LDX) Effective for Symptom Control in Children and Adolescents with ADHD
Date:10/21/2011

BASINGSTOKE, England, October 21, 2011 /PRNewswire/ --

Success of pivotal, phase III trial marks long-acting, prodrug stimulant LDX as potential new treatment option for ADHD in Europe

For international medical media only

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD)[1].  LDX is the first chemically formulated long-acting, prodrug of dexamfetamine for treatment of ADHD, and is currently licensed only in the US, Canada and Brazil.[1]

The study, conducted at 48 sites across Europe, showed that LDX demonstrated efficacy on the primary and key secondary measures compared to placebo, and a safety profile consistent with the known effects of amfetamine treatment and previous LDX trials.[1]  

"The results of this European study show that a once-daily morning dose of LDX was effective in children and adolescents with at least moderately symptomatic ADHD, and are consistent with those of previous studies conducted outside of Europe," said Dr Jeffrey Jonas, Senior Vice President of Research and Development for Shire's Specialty Pharmaceuticals business.  "These results provide important clinical trial data in support of LDX and its potential role as a new option for the treatment of ADHD in children and adolescents in Europe. The study will support the clinical package for European MAA* filing."

Moderately symptomatic ADHD is defined as having a baseline ADHD-RS-IV total score greater than or equal to 28.  The ADHD-RS-IV is designed to reflect current symptomatology of ADHD based on criteria set in the Diagnostic and Statis
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SOURCE Shire plc
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