Strong data on Shire's long-acting ADHD drug

Shire reported strong results from two Phase II trials of its investigational attention-deficit hyerpactivity disorder drug, SPD465 (triple-bead mixed amphetamine salts), at a major medical meeting of child and adolescent psychiatrists in San Diego, California, USA. The UK drugmaker stated that the agent improved ADHD symptoms in adults for up to 16 hours after administration and had a generally well-tolerated safety profile consistent with currently-marketed amphetamine products.

Timothy Wigal, lead investigator for both studies, stated that, "if approved, triple-bead MAS may be useful for maintaining adult ADHD symptom control throughout the day and during the evening hours, at work or at home, due to its long duration of action."

On July 21 Shire submitted a New Drug Application for the agent, which is now under review by US regulators. If approved, triple-bead MAS would be the first and only ADHD stimulant product designed to control inattention, hyperactivity and impulsivity in adults for up to 16 hours with one daily dose, Shire noted, making it a unique therapy option for over nine million American adults who currently exhibit symptoms of the behavioral disorder.