Philadelphia, US – July 22, 2005 – 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 product) as a once-daily treatment for adolescents aged 13 to 17 with attention deficit hyperactivity disorder (ADHD). Since October 2001, ADDERALL XR has been approved in the U.S. for treatment in children aged 6 to 12 years and since August 2004 in adults 18 years and older. ADDERALL XR is currently the most commonly prescribed brand of ADHD medication in the United States. “There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD’s potential impact on quality of life. Therefore, approval of an ADHD treatment for this underidentified age group is an important milestone,” explained Dr. Timothy Wilens of Massachusetts General Hospital. “The symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can have a significant impact on an individual’s family, academic performance, and overall quality of life. Stimulant therapies are effective and generally well tolerated, and have been used medically in patients for more than 60 years.”
ADHD affects approximately 3 to 7 percent of all school-age children, or approximately two million U.S. children, and is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. ADHD can have a profound effect on a child’s quality of life and can be serious enough to interfere beyond academics, leading to problems maintaining friendships, difficulties focusing on sports or other after-school activities, and challenges in relating well with other family members. Untreated ADHD has long-term adverse effects on academic performance, vocational success and social-emotional development. Evidence also suggests that many with untreated ADHD may be at risk for other problems, such as drug abuse, anti-social behavior and poor self-esteem. As they age, up to 65 percent of adolescents with ADHD may still exhibit symptoms into adulthood.
“The new adolescent labeling for ADDERALL XR offers health care providers, parents and patients continuity in the management of ADHD symptoms as children become older,” said Greg Flexter, Executive Vice President and General Manager, Shire North America. “ We are pleased that a thorough review by the FDA once again confirms the safety and efficacy of Adderall XR in another age group.”
The FDA based its approval on data that Shire provided in a supplement to its New Drug Application (sNDA). These data included the results of a pharmacokinetic study and a placebo-controlled, fixed-dose clinical trial of a range of doses of once-daily ADDERALL XR in adolescents with ADHD.
In a randomized, double-blind, placebo-controlled clinical trial, ADDERALL XR was proven to be significantly more effective than placebo in the treatment of ADHD symptoms in adolescents. ADDERALL XR was generally safe and well tolerated with adverse events similar to those seen in other populations. The most common adverse events were loss of appetite, insomnia, abdominal pain, and weight loss. The results of this study show that ADDERALL XR produces a positive clinical response in adolescents diagnosed with ADHD. The study showed ADDERALL XR at doses between 10 mg and 40 mg daily were statistically significantly superior to placebo (p<0<0
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