FDA approves Adderall XR (R) to treat ADHD...( mportantly 43 percent of those adults ...),Health

mportantly, 43 percent of those adults with ADHD report that they lost or left one or more of those jobs due in some part to their ADHD symptoms. Adults with ADHD are three times more likely to suffer from stress, depression or other problems with emotion; more likely to engage in harmful or antisocial behaviors; and report lower educational achievement, the survey found.

"We are very pleased to be bringing this effective therapy to adults whose lives are affected by ADHD symptoms." said Greg Flexter, Executive Vice President and General Manager of Sales and Marketing, Shire North America. "There has long been an unmet need for treatment among the adult population despite an increasing awareness of ADHD's potential impact on quality of life. We hope that this approved treatment option will encourage adults with ADHD to seek diagnosis and appropriate treatment. We also hope that treatment will help them pursue fulfilling, engaging lifestyles that are not affected by this condition."

The FDA based its approval on data from a four-week, multi-center, double-blind Phase 3 pivotal trial of 248 adult patients. ADDERALL XR, dosed once-daily, demonstrated significant control of ADHD symptoms at week one, the first evaluation period, and maintained this significant improvement throughout the four-week study. The primary measurement of symptom control was the ADHD Rating Scale (ADHD-RS), a validated scale used by clinicians to assess each of the 18 individual criteria symptoms of ADHD in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, a publication of the American Psychiatric Association.

At the end of the trial, the average ADHD-RS Total Scores for patients taking ADDERALL XR were 49% lower compared with the average scores at the beginning of the trial prior to receiving the medication. Shire recently presented long-term data using ADDERALL XR in adults. The data demonstrated that significant sympto
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12-Aug-2004

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