The Supplemental New Drug Application (sNDA), which was submitted to the FDA on 18 December 2002, included a comprehensive clinical programme in adult patients and supplements the largest ever open-label community assessment trial in pediatric ADHD research. ADDERALL XR is patented until 2018 and the adult indication is expected to receive a three-year Hatch-Waxman protection.
ADDERALL XR is a once daily formulation containing the same active ingredients as ADDERALL (R) (mixed salts of a single entity amphetamine product), which was developed by Shire's drug delivery division, Shire Laboratories Inc., using the Microtrol (R) oral controlled release technology. Shire already successfully markets ADDERALL XR for pediatric use in the US where it is recognized as the ADHD brand leader.
The adult market is roughly twice the size of the pediatric market 1. Approximately 66 pecent 2 of children with ADHD will continue to suffer from the disease throughout their adult life. The National Institute of Mental Health reported in 1999 that ADHD affected 8.2 million adults in the US, of which only 360,000 patients were receiving treatment. Non-treated, this disease can lead to psychological maladjustment, 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.
Dr Wilson Totten, Group R&D Director, said: "This is great news for adult ADHD patients and will give them a new choice of treatment which has already been widely successful with children. This further step for Shi
Contact: Michele Roy, Shire