Shire plc announced today that its collaborative partner New River Pharmaceuticals Inc. has received an approvable letter from the U.S. Food and Drug Administration
October 25, 2006 14:04

FDA Approves Pediatric ADHD Drug NRP104 October 10-Shire plc announced today that its collaborative partner New River Pharmaceuticals Inc. has received an approvable letter from the U.S. Food and Drug Administration for NRP104 (lisdexamfetamine dimesylate), for the treatment of pediatric ADHD. According to the FDA's letter, marketing approval of NRP104 is contingent upon final scheduling by the U.S. Drug Enforcement Administration. No additional studies have been requested by the FDA as a condition for approval of NRP104. Shire and New River will continue dialog with FDA officials to agree upon a final trade name. Shire and New River Pharmaceuticals are preparing for a product launch in Q2 2007, pending final labeling and scheduling discussions.

New Pediatric ADHD Drug Has Potential for Less Abuse
October 29, 2006 07:10

An investigational d-amphetamine prodrug appears to be effective in treating pediatric attention deficit hyperactivity disorder with the goal of less abuse potential than amphetamines. All dose levels of lisdexamfetamine (NRP104) were significantly more effective than the placebo. The result of a phase III study was presented at the American Academy of Child and Adolescent Psychiatry meeting.

The study included 290 patients aged six to 12 with a primary diagnosis of ADHD. The participants were randomized to receive 30 mg, 50 mg, or 70 mg daily or placebo for four weeks followed by a 30 day observation period. Researchers concluded that those who received the drug were much improved than those who received the placebo.
Adverse events were consistent with what has been seen with other amphetamines. No serious adverse events were reported and most were mild or moderate in severity. \
The study was supported by New River Pharmaceuticals, which developed the drug, and Shire, which will market it.

http://www.medpagetoday.com/Psychiatry/ADHD-ADD/tb/4391