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Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in healthy adult volunteers

ABSTRACT Objective: To evaluate the pharmacokinetics of lisdexamfetamine dimesylate (LDX; Vyvanse*) in fasting healthy adult volunteers. Background: LDX is the first pro-drug stimulant and is indicated for the treatment of attention-deficit/hyperactivity disorder. LDX was developed with the goal of providing an extended effect that is consistent throughout the day, with a reduced potential for abuse, overdose toxicity, and drug tampering. Methods: This was an open-label, multiple-dose phase 1 study. LDX 70 mg/d was administered in the morning to 12 subjects for 7 days. Twenty blood samples were drawn during the study. Descriptive statistics were used for pharmacokinetic parameters. Results: Based on Cmin, steady-state d-amphetamine concentration (20.6 ng/mL) was reached by day 5, whereas LDX was undetectable, and 95% of the d-amphetamine was eliminated within 48 hours following the final dose on day 7. At steady state, d-amphetamine achieved a mean ± standard deviation Cmax of 90.1 ± 29.6 ng/mL, with a median Tmax of 3.0 hours. The AUC0–inf for d-amphetamine was 1453 ± 645.7 ng.h/mL.Complete elimination of the pro-drug occurred approximately 6 hours following the final dose on day 7. Adverse events were mild to moderate and similar to other oral amphetamines. Conclusions: This study describes the steady-state pharmacokinetics of LDX, a new pro-drug stimulant. Possible study limitations include an open-label design and a small sample size.