SHIRE PRESENTS INTERIM DATA ON ADHD DRUG

Shire Pharmaceuticals and its collaborative partner New River Pharmaceuticals announced that their investigational attention-deficit/hyperactivity disorder (ADHD) treatment, lisdexamfetamine dimesylate (also known as NRP104 or LDX), yielded a 60 percent improvement in the primary rating scale scores for symptoms of ADHD in children ages 6 to 12 who received six months of treatment in an open-label Phase III study. Results also demonstrated that at six months, 95 percent of children taking lisdexamfetamine dimesylate produced a "much improved" or "very much improved" rating on the Clinical Global Impressions Improvement score.

The subjects in this study had previously participated in either of two blinded clinical trials of lisdexamfetamine dimesylate. All patients in the current trial received 30 mg of the drug in the first week. Investigators titrated patients' daily dosage by 20 mg at weekly intervals during subsequent visits to achieve optimal efficacy and tolerability. The maximum daily dose was 70 mg.

In this study of 269 children with ADHD, six months of treatment resulted in significant reductions in the participants' average total scores on the Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV). Specifically, the children had an average reduction of 26.9 points, which represents an average improvement of more than 60 percent. ADHD-RS-IV, the primary efficacy measurement tool for the study, is a standard test for assessing symptoms of ADHD.

Final results of this study, which will assess lisdexamfetamine dimesylate treatment in children with ADHD for one year, are expected in mid-2007. New River received an approvable letter from the FDA for the drug in early October. According to the FDA's letter, marketing approval is contingent upon final scheduling by the Drug Enforcement Administration. The FDA has not requested any additional studies. Shire and New River are preparing for a product launch in the second quarter of 2007, pending final labeling and scheduling discussions.