Long-term study proves ADDERALL XR is a safe and effective option to treat adults...( New York NY May 6 2004 Shire Pharma...),Health

New York, NY, May 6, 2004 Shire Pharmaceuticals Group plc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN) announced that adults with attention-deficit/hyperactivity disorder (ADHD) experienced significant ADHD symptom control when treated with once-daily ADDERALL XR (a mixed salts amphetamine product). The 18-month interim analysis of a two-year Phase III trial led by Harvard investigators was discussed today during a platform presentation at the American Psychiatric Association (APA) annual meeting in New York City.

"Adults with ADHD can benefit from treatment with ADDERALL XR over the long-term because it can improve their ability to maintain focus, concentrate, and pay attention for longer periods of time, which may enable them to achieve more in professional, academic and social settings," said lead investigator Joseph Biederman, M.D., professor of psychiatry at Harvard Medical School.

Up to 65 percent of children with ADHD may still exhibit symptoms into adulthood and an estimated 4.4 percent of the U.S. adult populations are affected by ADHD. If left untreated, ADHD may seriously and adversely affect patients as well as their families, friends and coworkers. The disorder's symptoms of inattention and impulsivity, if untreated, can result in poor performance in the workplace and may increase adults' risk for other problems, such as drug abuse, anti-social behavior, and poor self-esteem, all of which can further impair social and family relationships, Biederman explained.

After these adult patients completed a four-week placebo-controlled trial with ADDERALL XR, they entered into a two-year extension study. The 18-month interim analysis of this extension study revealed that they maintained a significant reduction in their ADHD symptoms when treated with ADDERALL XR. For many patients, this sustained reduction in ADHD symptoms was at doses equivalent to those used in the initial four-week study, which reinforced previous findings that pa
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Contact: Marion Glick
marion.glick@porternovelli.com
212-601-8273
Porter Novelli
6-May-2004

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