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| |  FDA Approves Adderall XR (Amphetamine Product) For Once-Daily Treatment Of Attention Deficit/Hyperactivity Disorder FLORENCE, KY -- October 12, 2001 -- Shire Pharmaceuticals Group plc announced today that the U.S. Food and Drug Administration approved Adderall XR™ (mixed salts of a single-entity amphetamine product) for the treatment of attention deficit/hyperactivity disorder (ADHD). Adderall XR, a novel, extended-release formulation of Shire's well tolerated and effective ADHD treatment Adderall®(1)(2)(3), is designed to provide symptom control in the morning and throughout the day with just one morning dose -- an increasingly important benefit for children with ADHD and their caregivers. The DSM-IV, the leading diagnostic manual for psychiatrists, underscores the pervasive nature of ADHD, defining it as a disorder that occurs in multiple settings throughout the course of a day. "Once-a-day medications, such as Adderall XR, are an important new option for parents and patients, and represent the future of ADHD therapy," said Dr. Joseph Biederman, Professor of Psychiatry at Harvard Medical School, who led a study of Adderall XR. "ADHD is an all-day disorder, affecting children as they study, play, and participate in sports and other extracurricular activities. Adderall XR provides the long-acting treatment children with ADHD need, helping them achieve their full potential inside and outside the classroom." The FDA based its approval of Adderall XR on results of two studies representing classroom and naturalistic/home settings that found that the medication dramatically helps reduce hyperactivity and impulsivity in children with ADHD, and improves their ability to work, focus, and learn. The American Academy of Pediatrics treatment guidelines, released in early October, confirm that ADHD is a persistent and chronic disorder that often is best treated to maximize function across multiple domains, including schoolwork, home work, social stigma and peer-to-peer interaction. Studies show the effects of Adderall XR last throughout the afternoon, a time when many children participate in after-school activities or do homework, and thus need a long- acting treatment. Most other ADHD medications must be taken during the school day, or immediately after school, making school personnel or the child responsible for the midday dose. But many schools lack school nurses, which often puts the responsibility of dispensing medication on people with no medical background, such as school secretaries, parent aides, and teachers. "Avoiding having to take medication in school is an important benefit, as it eases the burden on school nurses who have a variety of responsibilities, including tending to sick students and conducting health education programs in the classroom," said Dr. Judith Vessey, Professor of Nursing at Boston College and research consultant to the National Association of School Nurses. "Once- daily dosing with long-acting medications does not just benefit the child, but also the people who support the child in his or her treatment." "By eliminating the need for children to bring their medication to school, the convenient dosing regimen of Adderall XR decreases social stigma issues, as well as the risk of medication misuse," added Dr. Biederman. The benefits of Adderall XR have been demonstrated in two well-controlled trials with more than 600 patients at more than 50 sites. A laboratory classroom study found that Adderall XR provides longer-lasting symptom control than original Adderall. In the study, a single morning dose of Adderall XR 30mg demonstrated statistically significant superiority in ADHD symptom control, compared with placebo, at all observed time points from 1.5 hours to 12 hours post dose. The symptom control continued after the benefit of a single dose of conventional Adderall would have expired. In a second clinical study involving more than 500 children with ADHD, Adderall XR demonstrated statistically significant improvement in attention and behavior in children with ADHD, as measured by parents and teachers. The improvement in symptom control observed at 4 p.m. was comparable to the significant improvement observed at 10 a.m. earlier the same day. The most commonly observed side effects in the studies were consistent with those typically seen with psychostimulant medications and included anorexia, insomnia, abdominal pain, emotional lability, and nervousness. The majority of these side effects were mild and did not escalate. In clinical studies, fewer patients given Adderall XR had an adverse event that led to discontinuation of treatment, compared with those given placebo. "Adderall XR is a welcome new treatment option for families affected by ADHD because the symptoms of the disorder do not stop when the school day ends," said Dr. Alex Michaels, Vice President of Medical Affairs at Shire Pharmaceutical Development. "The approval of Adderall XR represents our commitment toward providing the best in ADHD treatment and support -- including working to ensure that parents are in control of their children's medication." ADHD is considered the most commonly diagnosed psychiatric disorder among school-aged children.(4) Children with ADHD often are inattentive, impulsive, and hyperactive -- difficulties serious enough to interfere with their ability to function normally in academic or social settings. Up to 66 percent of children with ADHD will continue to show symptoms into adulthood.(5) Although there is no "cure" for ADHD, physicians, parents, teachers, nurses, and advocates are finding ways to help people with the condition learn to adapt to their academic, social, and work settings. ADHD usually can be successfully managed with a combination of treatments, including educational approaches, psychological and behavioral therapies, and medication. A recent government-sponsored clinical trial found that therapies that include carefully monitored medication are more effective than those that do not, such as behavioral therapy alone.(6) Medication should be considered part of an overall multimodal treatment plan for ADHD. Shire supports the use of Adderall XR only after a thorough assessment and diagnosis of ADHD by a physician. References SOURCE: Shire Pharmaceuticals Group plc
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