Shire plc, a global specialty biopharmaceutical company, 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). The 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.
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.
“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 VP of R&D 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 = 28. The ADHD-RS-IV is designed to reflect current symptomatology of ADHD based on criteria set in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Series (DSM-IV), with a total score ranging from 0 (reflecting no symptoms) to 54 (reflecting severe symptoms).
In the study, 336 patients were randomised to receive LDX, osmotic-controlled extended-release methylphenidate (OROS-MPH) or placebo, over a period of seven weeks. The OROS-MPH active reference treatment arm was included to provide data on a current standard therapy for ADHD in Europe. The primary comparison is LDX vs placebo. Formal comparisons between LDX and OROS-MPH were not planned. Study exclusion criteria included, but were not limited to: significant symptoms resulting from comorbid psychiatric diagnosis; symptoms that may have contraindicated LDX and/or OROS-MPH treatment such as a history of drug abuse; history of serious cardiac abnormalities; and hypersensitivity or intolerance to amfetamine and/or methylphenidate.