Shire issues positive phase III results for LDX

Shire has announced a positive outcome for the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX).

The product, which is the first chemically formulated long-acting prodrug of dexamfetamine for attention deficit/hyperactivity disorder (ADHD), was tested by the biopharmaceutical company at 48 sites across Europe.

It was shown to demonstrate efficacy on primary and key secondary measures compared with placebo, as well as achieving a safety profile consistent with previous trials involving LDX.

"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," commented Dr Jeffrey Jonas, senior vice-president of research and development for Shire's Specialty Pharmaceuticals business.

ADHD is the most common behavioural disorder in the UK. The term is used to define a group of behavioural symptoms that include inattentiveness, hyperactivity and impulsiveness.

It is estimated that the condition affects between three and nine percent of school-aged children and young people.