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



Shire and New River Post Data on ADHD Trial


Posted on 2006-05-30 15:07:00



Specialty drug makers Shire PLC and New River Pharmaceuticals Inc. said Wednesday that two clinical trials on their experimental attention deficit treatment showed the drug significantly reduced symptoms in children.

In a late-stage clinical study, 230 children, aged six to 12, with attention deficit hyperactivity disorder were given either lisdexamfetamine dimesylate or a placebo. According to scores meant to evaluate the severity of ADHD symptoms, symptoms of children given the treatment were 59 percent less severe than those of patients who had received the placebo.

Also, fifty children with ADHD in a mid-stage clinical were given lisdexamfetamine dimesylate, mixed extended-release amphetamine salts, or placebo and then tested on a different behavioral scale. Children given the treatment or the salts showed significant improvement compared with placebo.

New River developed the treatment under a partnership it signed with Shire in January 2005. In December 2005, New River filed a marketing application with the Food and Drug Administration. The application is still under review.

Separately, New River said it started a late-stage ADHD clinical of the treatment in adults.