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Pharmacokinetics and pharmacodynamics of guanfacine extended release in adolescents aged 13–17 years with attention‐deficit/hyperactivity disorder

The safety and efficacy of guanfacine extended release (up to 4 mg/day) for attention‐deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6–17 years is well documented. Data suggest that weight‐adjusted doses of guanfacine extended release >0.08 mg/kg but ≤0.12 mg/kg, if tolerated, may provide additional clinical benefits. For many adolescents, such dosing would exceed 4 mg/day, the highest approved dose. This open‐label multicenter study evaluated the safety, tolerability, and steady‐state pharmacokinetics of guanfacine extended release at escalated forced doses ≤9 mg/day in adolescents (N = 31) aged 13–17 years with ADHD. Following doses of approximately 0.12 mg/kg, the highest weight group (>70–90 kg) exhibited lower mean clearance at steady‐state than the lowest weight group (≥30–50 kg). Consistent with its known antihypertensive effects, guanfacine extended release was associated with dose‐dependent decreases in blood pressure (BP) and heart rate (HR). The physiologic response of increased BP upon standing was blunted in a dose‐related manner while the physiologic response of increased HR upon standing was not substantively affected. The most common treatment‐emergent adverse events were somnolence, dizziness, and sinus bradycardia. These results, and those from prior studies, support further examination of the efficacy and safety of higher weight‐adjusted doses of guanfacine extended release for ADHD.