Shire PLC announced last week that it has submitted a new drug application (NDA) to the US Food and Drug Administration for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. The application is subject to a 12-month FDA review period. SPD465 has the same active ingredient as the popular drug Adderall XR®, but is designed to provide ADHD symptom control for up to 16 hours. If approved, this novel product will be the sole ADHD stimulant to control inattention, hyperactivity and impulsivity for this long a duration.
Matthew Emmens, Shire CEO, said, “The FDA filing for SPD465 is another milestone met and underscores Shire’s commitment to be the market leader in ADHD treatments by offering patients new solutions to manage this chronic disorder. If approved, the 16-hour formulation of SPD465 would make it the longest-acting stimulant medication for adult patients with ADHD, while also providing the efficacy of Adderall XR, the most prescribed brand of ADHD treatment.”
ADHD is a neurological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity more frequent and severe than typical in non-afflicted individuals of similar age and maturity.
Scientists now agree that up to 65% of adolescents with ADHD will continue to have the disorder as adults. Over 9 million American men and women currently exhibit symptoms of ADHD, according to the National Institute of Mental Health (NIMH). Around 36% of ADHD prescriptions are currently written for adult sufferers.
© Copyright 2007 Insight Journal Online Magazine.
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