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FDA approves Adderall XR (R) to treat ADHD in adults

Philadelphia, Pa. Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR® (mixed salts of a single-entity amphetamine) as a once-daily treatment for adults with Attention Deficit Hyperactivity Disorder (ADHD). Since 2001, ADDERALL XR has been approved in the U.S. for the treatment of ADHD in children.

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, this disorder may lead to other psychological difficulties, such as depression, as well as occupational and social disability. Appropriate diagnosis and treatment of ADHD in adults helps improve self-esteem, work performance and skills, educational attainment and social competencies. Over eight million adults in the U.S. may exhibit the symptoms of ADHD, while only 600,000 are actively taking medication.

"ADHD in adult patients may significantly impair a person's social and family relationships, as well as his or her career," said Richard H. Weisler, M.D., adjunct professor of psychiatry at the University of North Carolina, Chapel Hill (UNC) School of Medicine and principal investigator for ADDERALL XR studies in adults. "Stimulant therapies, like ADDERALL XR, have been used successfully in patients for more than 60 years. It's an important step that ADDERALL XR is the first stimulant to be approved for use in adults."

According to a recent national survey, "Capturing America's Attention," the repercussions of untreated ADHD may have limited adults with the condition from reaching their full academic and occupational potential, and limited their satisfaction with themselves and their relationships. Adults with ADHD are twice as likely to be divorced or separated and have had almost twice as many jobs in the past ten years compared to adults without ADHD. I
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12-Aug-2004


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