Shire plc has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in the adult population.
The application is subject to a 12-month FDA review period. SPD465 has the same active ingredient as Adderall XR (mixed salts of a single-entity amphetamine product), but is designed to provide ADHD symptom control for up to 16 hours. Upon approval, this novel product will be the first and only ADHD stimulant product, which controls in attention, hyperactivity and impulsivity for up to 16 hours.
"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," stated Matthew Emmens, Shire CEO. "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, the most prescribed brand of ADHD treatment."
ADHD is a neurological brain disorder, that manifests as a persistent pattern of in attention or hyperactivity-impulsivity, which is more frequent and severe, than typically observed in individuals at a comparable age and maturity level. Scientists now agree that up to 65 per cent of adolescents with ADHD will continue to have the ADHD diagnosis as adults. More than 9 million American adults currently exhibit symptoms of ADHD, based on independent research by the National Institute of Mental Health. Approximately 36 per cent of ADHD prescriptions are currently written for adult patients.
Adderall was generally well tolerated in clinical studies. The most common side effects in studies included: children - decreased appetite, difficulty falling asleep, stomach-ache, and emotional liability; adolescents - loss of appetite, difficulty falling asleep, stomach-ache, and weight loss; adults - dry mouth, loss of appetite, difficulty falling asleep, headache, and weight loss.