Shire files SPD465 for adult ADHD

UK drugmaker Shire say that it has submitted a New Drug Application to the US Food and Drug Administration for SPD465, an investigational amphetamine compound for the treatment of attention-deficit hyperactivity disorder in the adult population.

The application is subject to a 12-month FDA review period. SPD465 has the same active ingredient as the firm's already-marketed 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 that controls inattention, hyperactivity and impulsivity for up to 16 hours, according to Shire.

"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 chief executive. "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," he added.