▴SLI-381 is an extended-release formulation of short-acting Adderall®, a racemic mixture of dextro- and levo-isomers of amphetamine salts. Drug-containing microbeads within the SLI-381 capsule give a double-pulsed delivery, similar to that achieved by two equal doses of the short-acting formulation administered 4 hours apart.
▴In an intent-to-treat analysis of a 3-week, double-blind study in 563 children with attention-deficit hyperactivity disorder (ADHD), SLI-381 10, 20 or 30mg once daily improved mean morning and afternoon behaviour scores compared with baseline significantly more than placebo (p < 0.001 for all comparisons), as assessed by the Connors Global Index Scale for teachers (CGIS-T). Following treatment, CGIS-T scores were similar to those reported in children without ADHD.
▴In the same study, a dose-response relationship was observed, and increasing the dosage of SLI-381 by 10mg at weekly intervals, to a maximum of 30mg once daily, resulted in further improvements in the scores of the CGIS-T.
▴After early morning administration of SLI-381 in this double-blind study, late-afternoon scores of the CGIS for parents were similar to morning scores.
▴SLI-381 was generally well tolerated in randomised trials in children with ADHD for up to 24 months. Overall, adverse events were mild to moderate in intensity.
KeywordsAmphetamine Emotional Lability Clinical Global Impression Scale Adderall Psychostimulant Medication
- 2.Biederman J. Attention-deficit/hyperactivity disorder: a life-span perspective. J Clin Psychiatry 1998; 59 Suppl. 7: 4–16Google Scholar
- 7.Adderall XR: prescribing information. Florence (KY): Shire US Inc., 2002Google Scholar
- 8.Tulloch SJ, Zhang Y, McLean A, et al. SLI381 (Adderall XR), a two-component, extended-release formulation of mixed amphetamine salts: bioavailability of three test formulations and comparison of fasted, fed, and sprinkled administration. Pharmacotherapy 2002 Nov; 22(11): 1405–15PubMedCrossRefGoogle Scholar
- 11.Ambrosini PJ, Lopez FA, Chandler MC, et al. An open-label, community-assessment trial of Adderall XR in pediatric ADHD [abstract no. 64 and oral presentation]. American Psychiatric Association Annual Meeting: Syllabus and Proceedings Summary; 2003 May 17–22; San Francisco, 27Google Scholar
- 12.Sallee FR, Ambrosini PJ, Lopez FA, et al. An open-label trial of Adderall XR: quality-of-life assessments [abstract no. 62 and oral presentation]. American Psychiatric Association Annual Meeting: Syllabus and Proceedings Summary; 2003 May 17–22; San Francisco, 26Google Scholar
- 13.Chandler MC, Lopez F, Biederman J. Long-term safety and efficacy of Adderall XR in children with ADHD [abstract no. 63]. American Psychiatric Association Annual Meeting: Syllabus and Proceedings Summary; 2003 May 17–22; San Francisco, 26-7Google Scholar
- 14.Lopez FA, Chandler MC, Biederman J, et al. Long-term Adderall XR treatment improves quality of life in ADHD children [abstract no. 650 and poster]. American Psychiatric Association Annual Meeting; 2003 May 17–22; San Francisco, 243Google Scholar
- 15.Conners KC. Normative samples and psychometric properties of the CRS-R. In: Sitarenios G, Parker JDA, Caddey M, et al, editors. Conners’ rating scales — revised: technical manual. Toronto (ON): Multi-Health Systems Inc., 1997: 97–117Google Scholar