Breaking News From Pharma & Bio Ingredients Subscribe via RSS Subscribe via RSS



ADHD Treatment Yields 60% Improvement


Posted on 2006-10-30 11:55:00



Shire plc and its collaborative partner New River Pharmaceuticals Inc. announced today that their investigational ADHD treatment, lisdexamfetamine dimesylate (also known as NRP104 or LDX), yielded a 60 percent improvement in the primary rating scale scores for symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 years who received six months of treatment in an open-label phase III study. Results also demonstrated that at 6 months, 95 percent of children taking lisdexamfetamine dimesylate (NRP104/LDX) produced a "much improved" or "very much improved" rating on the Clinical Global Impressions - Improvement score. These results were presented last weekend at a national meeting of child and adolescent psychiatrists.

Final results of this study, which will assess lisdexamfetamine dimesylate (NRP104/LDX) treatment in children with ADHD for one year, are expected in mid-2007.

"This study further demonstrates the potential of lisdexamfetamine dimesylate to be an effective treatment option for children with ADHD," said Ann Childress, M.D., study investigator and president at the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, Nev. "Lisdexamfetamine dimesylate was designed to offer the effectiveness of a stimulant with a novel prodrug formulation that is inactive until metabolized in the body."

New River Pharmaceuticals designed lisdexamfetamine dimesylate as a new ADHD medication in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. Designed to provide efficacy throughout the day through 6 p.m., lisdexamfetamine dimesylate (NRP104/LDX) remains inactive until converted in the body and the active drug is released. In January 2005, New River signed a collaborative agreement with Shire to develop and commercialize lisdexamfetamine dimesylate (NRP104/LDX). New River received an approvable letter from the U.S. Food and Drug Administration (FDA) for lisdexamfetamine dimesylate (NRP104/LDX) on October 6, 2006. According to the FDA's letter, marketing approval is contingent upon final scheduling by the U.S. Drug Enforcement Administration (DEA). The FDA has not requested any additional studies. Shire and New River are preparing for a product launch in Q2 2007, pending final labeling and scheduling discussions.


NEWS ARCHIVES

2008

2007

2006

2005

2004

NEWSLETTER SIGNUP