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Experimental ADHD Drug Reduces Symptoms and Chances of Abuse

(May 24, 2006) -- Two clinical trials on an experimental attention deficit treatment showed the drug significantly reduced ADHD 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 trial 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 Pharmaceuticals 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.

One other benefit of this experimental ADHD medication compared to other stimulants is the reduced chance it will be abused by non-ADHD users. The chemical makeup of the drug and the manufacturing process allows the active ingredient to be gradually released which may make drug tampering difficult and impractical. NRP104 (lisdexamfetamine dimesylate) was designed with the expectation to have comparable efficacy and tolerability to currently marketed once daily extended-release stimulants with reduced potential for abuse, diversion and overdose toxicity.

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

Last updated: 05/06

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