A phase II trial of lisdexamfetamine dimesylate (NRP104), also presented at APA today, demonstrated a statistically significant reduction in ADHD symptoms comparable to mixed amphetamine salts extended-release (MAS XR). Both products were studied versus placebo in children aged 6 to 12 years with ADHD.
These studies showed that NRP104 significantly reduced ADHD symptoms and was well-tolerated, said Joseph Biederman, M.D., professor of psychiatry at Harvard Medical School and director of Pediatric Psychopharmacology at Massachusetts General Hospital. Dr. Biederman led both of the NRP104 studies presented at the APA meeting.
New River Pharmaceuticals Inc. developed NRP104 and on January 31, 2005, signed a collaborative agreement with Shire to develop and commercialize the product. On December 6, 2005 New River filed a New Drug Application with U.S. Food and Drug Administration to evaluate NRP104 for the treatment of ADHD. This application is currently under review.
Phase III Study Results of NRP104
In the phase III study, 30-milligram (mg), 50 mg, and 70 mg QD doses of lisdexamfetamine dimesylate (NRP104) demonstrated significant improvements in average ADHD symptoms compared with placebo (P<0.0001) after four weeks of once-daily treatment, as measured by 230 childrens scores on the ADHD Rating Scale (ADHD-RS). ADHD-RS is a standard test for diagnosing ADHD in children and adolescents and for assessing their response to treatment. The scale, which c
Contact: Matthew Cabrey, Shire