If approved the product will be the first and only ADHD stimulant product that controls inattention, hyperactivity and impulsivity for up to 16 hours. The application is subject to a 12-month FDA review period.
The most common adverse events reported in SPD465 phase III studies were insomnia, decreased appetite and stomachache.
“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,” said Matthew Emmens, Shire’s 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 XR, the most prescribed brand of ADHD treatment.”
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 typically observed in individuals at a comparable age and maturity level.