New River NRP104 Phase III data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
New River's d-amphetamine prodrug NRP104 showed statistically significant results for primary and secondary endpoints in a Phase III study of children with attention deficit hyperactivity disorder, the firm reports May 23. The study of 285 patients aged six to 12 showed that each of three doses of NRP104 had a significant outcome for the ADHD Rating Scale (primary) and the Conners Parent Rating Scale (p<0.0001), New River said. New River is collaborating with Shire on NRP104; the firms signed a global commercialization deal in January. NRP104 is expected to reach the market by 2006 (1Pharmaceutical Approvals Monthly February 2005, p. 19)...