Shire, New River present positive study results for ADHD drug NRP104

By Elaine Rigoli

Tampa, Fla., May 24 - Shire plc and New River Pharmaceuticals, Inc. announced that treatment with the investigational drug lisdexamfetamine dimesylate (NRP104) demonstrated statistically significant reduction in the symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged six to 12 years, according to the results of a phase 3 trial.

The company also said a phase 2 trial of NRP104 demonstrated a statistically significant reduction in ADHD symptoms comparable to mixed amphetamine salts extended-release (MAS XR). Both products were studied versus a placebo in children aged six to 12 years with ADHD.

In the phase 3 study, 30 mg, 50 mg and 70 mg of NRP104 demonstrated significant improvements in average ADHD symptoms compared with a placebo after four weeks of once-daily treatment, according to a news release.

Average reductions in ADHD scores were 51% (21.8 points), 54% (23.4 points) and 59% (26.7 points) for the 30 mg, 50 mg and 70 mg dosage strengths, respectively, compared to baseline.

All three NRP104 doses produced significant average differences in the scores during the first week of treatment. Of the participants, 36% had previously received treatment for ADHD, the release said.

London-based Shire is a specialty pharmaceutical company that focuses on meeting the needs of the specialist physician.

New River Pharmaceuticals is a specialty pharmaceutical company based in Radford, Va.

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