NEW RIVER COMPLETES ENROLLMENT IN ADULT ADHD STUDY

New River Pharmaceuticals has announced that the enrollment numbers have been met for the company's NRP104.303 study, a Phase III trial to examine the safety and efficacy of NRP104 as a treatment for attention-deficit/hyperactivity disorder (ADHD) in adult populations (ages 18 to 52). The company expects to file a supplemental new drug application for the adult indication in the second quarter of 2007.

NRP104 (lisdexamfetamine dimesylate) is the subject of a collaboration agreement between New River and Shire. The drug is currently under review by the FDA for the treatment of ADHD in pediatric populations (ages 6 to 12).

The company said that the desired safety and efficacy endpoints were met in the company's NRP104.302 study, a long-term, open-label, single-arm study of NRP104 in doses of 30, 50 or 70 mg per day in pediatric patients diagnosed with ADHD. A total of 293 patients with ADHD were enrolled in this multicenter trial, the results of which have been submitted to the FDA.