Adderall XR (R) Approved for the Treatment of ADHD in Adolescents
Jul 25, 2005, 11:00, Reviewed by: Dr.
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"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."
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By Shire Pharmaceuticals Group plc,
Shire Pharmaceuticals Group plc announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR(R) (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 
- United States Food and Drug Administration
www.AdderallXR.com
For further information please contact:
Media Marion Glick (Porter Novelli) (212) 601-8273
Janice Miller (Porter Novelli) (212) 601-8176
Notes to editors
Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.
For further information on ADDERALL XR, please visit the ADDERALL XR website at http://www.AdderallXR.com .
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to Health Canada's suspension of ADDERALL XR(R) sales in Canada and the expected product approval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire's ability to consummate and benefit from its proposed acquisition of Transkaryotic Therapies, Inc., Shire's ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.
CONTACT: Marion Glick, +1-212-601-8273, or Janice Miller, +1-212-601-8176both of Porter Novelli for Shire Pharmaceuticals Group plc
Web site: http://www.AdderallXR.com/
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