In the study investigators randomized healthy adults to either of two treatments, once-daily SPD465 or Adderall XR followed by mixed amphetamine salts immediate release (MAS IR) administered eight hours later.
The bioequivalence of the two medication regimens is supported by the pharmacokinetic data collected for both d-amphetamine and l-amphetamine. Maximum plasma concentrations for both d-amphetamine and l-amphetamine were similar between the SPD465 group and the Adderall XR plus MAS IR group. No clinically meaningful differences occurred between the two groups regarding adverse events.
“Adults with ADHD are particularly challenged by a normal day’s activities that often extend into the evening, and SPD465 offers the possibility of full-day symptom control,” said Lenard Adler, director of the Adult ADHD Program at New York University School of Medicine.
In July 2006, Shire submitted a new drug application for SPD465, which is now under FDA review. If approved, SPD465 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. More than nine million American adults currently exhibit symptoms of ADHD.