New River Pharmaceuticals in US files new drug application for treatment of children with ADHD
Virginia-based New River Pharmaceuticals has filed with the US Food and Drug Administration a new drug application (NDA) for the compound NRP104 to be used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged between 6 and 12.
Virginia-based New River Pharmaceuticals has filed with the US Food and Drug Administration a new drug application (NDA) for the compound NRP104 to be used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged between 6 and 12.
NRP104 is an amphetamine derivative and the subject of a collaboration agreement between New River and Shire plc. New River also presented results of several studies to the FDA that demonstrated it would be more difficult to extract amphetamine from NRP104 than from other widely available alternatives.
Suma Krishnan, New River's vice-president, product development, said: 'We are pleased that this application has been submitted on schedule, and we anticipate the approval and subsequent launch of NRP104 in 2006.'
New River also has a Phase I/II dose ranging study underway for NRP290, the company's hydrocodone derivative for the treatment of acute pain. The company expects to file an investigational new drug application (IND) with the FDA for NRP388 by the end of the second quarter of 2006.
NRP388 involves a technology licensed from the Gallo Clinic and Research Center at the University of California, San Francisco, used to treat chronic pain and reduce opioid tolerance.