SLI-381 (Adderall XR)

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 30 mg 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 30 mg 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.