SLI381 (
Adderall-XR) is a longer-acting form of
Adderall, a compound of mixed
amphetamine salts that is now the most frequently prescribed brand of psychostimulant medication for
attention-deficit hyperactivity disorder (
ADHD) in the US. It has been demonstrated to be a safe and effective treatment for
ADHD in school-age children. To date, the efficacy of
SLI381 has been evaluated in controlled studies of over 500 patients. The
therapeutic effects of
SLI381 on the core symptoms of
ADHD, as well as the duration of action of the formulation, have been demonstrated to persist for 12 h, with both greater efficacy and duration of effects seen at higher doses. Both behavioural and cognitive performance measures are improved throughout the school day and into post-school activities. The incidence of common stimulant-emergent side effects with
SLI381 was no different than that seen with the existing
Adderall preparation. Additionally, the frequency with which most stimulant-related side effects were experienced did not demonstrate a consistent dose-related incidence, with the exception of
anorexia.
SLI381 received a letter of approvability in August 2001 and will probably be approved in the immediate future by the US FDA. This formulation represents a valuable addition to the available pharmacotherapeutic options for
ADHD by providing an
amphetamine-based stimulant offering the advantages of once-daily dosing accompanied by the clinical benefits of
ADHD symptom control associated with the now widely used
Adderall preparation.