Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall. Journal of the American Academy of Child and Adolescent Psychiatry. [J Am Acad Child Adolesc Psychiatry] Journal article | | Title | Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall. | | Author(s) | McGough JJ, Biederman J, Greenhill LL, McCracken JT, Spencer TJ, Posner K, Wigal S, Gornbein J, Tulloch S, Swanson JM | | Institution | Department of Psychiatry and Biobehavioral Sciences, Division of Child and Adolescent Psychiatry, UCLA Neuropsychiatric Institute, Los Angeles, USA. jmcgough@mednet.ucla.edu | | Source | J Am Acad Child Adolesc Psychiatry 2003 Jun; 42(6):684-91. | | MeSH | Amphetamines
Attention Deficit Disorder with Hyperactivity
Central Nervous System Stimulants
Child
Cluster Analysis
Comparative Study
Cross-Over Studies
Delayed-Action Preparations
Double-Blind Method
Female
Humans
Male
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
| | Abstract | OBJECTIVE: To assess the pharmacokinetic (PK) properties of a single daily dose of Adderall (mixed amphetamine salts) and the extended-release formulation, SLI381 (ADDERALL XR), in pediatric attention-deficit/hyperactivity disorder (ADHD).
METHOD: Fifty-one children (aged 6-12 years) with ADHD participated in a 6-week, seven-visit, PK and pharmacodynamic study. PK sampling occurred during visit 1 and again at visit 7. At visit 1, subjects received an initial oral dose of SLI381, 20 mg. At visit 7 subjects completed 1 week of medication treatment following random assignment to once-daily orally dosed SLI381 10 mg, 20 mg, or 30 mg; Adderall 10 mg; or placebo.
RESULTS: PK parameters evidenced substantial intersubject variability (coefficients of variation = 28-56%). Time to maximum concentration (Tmax) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine (t = -2.35, p = .04, df = 8.6) and 3.2 hours for levoamphetamine (t = -2.39, p = .04, df = 9.2). The d- and l-isomer concentrations were highly correlated and approximated a 3:1 ratio.
CONCLUSIONS: SLI381 showed extended Tmax values compared with Adderall and appears suitable for once-daily dosing. Intersubject variability underscores the need for individual dose titration. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 12921476 |
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