New River Pharmaceuticals Provides Update on Clinical Trials and Pipeline

New River Pharmaceuticals has updated the status of its various pipeline product candidates.

Clinical trials on the investigational new drug NRP104 are proceeding as anticipated. Patient enrollment has been completed in the pivotal Phase III clinical trial evaluating NRP104, a conditionally bioreversible derivative of d-amphetamine, in pediatric patients for the treatment of attention-deficit/hyperactivity disorder (ADHD). A total of 301 patients with ADHD were enrolled in this multicenter trial. The primary objective of this study is to assess the efficacy and safety of NRP104 compared to placebo in the treatment of children aged 6-12 years with ADHD.

In addition to the aforementioned Phase III clinical trial, a Phase II study designed to assess the efficacy and duration of action of NRP104 in children (ages 6 to 12) with ADHD has been completed and the data are currently being analyzed. A total of 52 patients with ADHD completed this multicenter study.