Extended-Release Oral Suspension for ADHD Effective, Well Tolerated in Children
SAN ANTONIO, TX—At the U.S. Mental Health & Psychiatric Congress, researchers from the Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, presented that amphetamine extended-release oral suspension was effective in reducing symptoms vs. placebo for the treatment of children aged 6–12 years with attention deficit/hyperactivity disorder (ADHD).
Current guidelines recommend a combination of behavioral therapy and pharmacologic intervention for treating ADHD. Stimulant drugs, which include amphetamine, is considered a first-line treatment. With ~70% of younger patients having difficulties with swallowing pills and capsules, extended-release liquid formulations are preferred. Dyanavel XR (amphetamine extended-release) oral suspension, gained approval from the Food and Drug Administration (FDA) for use in children aged 6–17 years.
Ann C. Childress, MD, lead author of the study, and colleagues reported on a dose-optimized, randomized, double-blind, placebo-controlled laboratory classroom study of 108 children aged 6–12 years with ADHD. The primary efficacy endpoint was change from pre-dose in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined score at 4 hours post-dosing. Major secondary endpoints included onset and duration of clinical effect as measured by change in pre-dose SKAMP-Combined scores at 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose. During the 5-week open-label phase, study patients were initiated on 2.5mg or 5mg amphetamine extended-release oral suspension once daily; the dose could be titrated up to a maximum daily dose 20mg. The patients were then randomized to either amphetamine extended-release oral suspension at the optimized 10mg–20mg or placebo for 1 week.
Safety was evaluated by incidence and severity of adverse events. At each visit, vital signs (eg, blood pressure, pulse) were measured. In addition, the frequency of suicidality was assessed using the Columbia Suicide Severity Rating (C-SSRS).
Of the total enrolled children, 99 completed the study. The team reported that the primary efficacy endpoint of change from pre-dose in the SKAMP-Combined score at 4 hours post-dose was met (least squares [LS] mean treatment difference 95% CI: -14.8 [-17.9, -11.6]; P<0.0001). The treatment effect was seen at 1 hour post-dose the earliest time point assessed (treatment difference LS mean -10.2; P<0.0001). This effect was found to persist until 13 hours post-dose, the final time point assessed (treatment difference LS mean -9.2; P<0.0001).
"At each post-dose time point measured, the change from pre-dose SKAMP-Combined score was statistically significantly improved following treatment with amphetamine extended-release oral suspension vs. placebo," noted Dr. Childress.
Regarding safety, 59.8% of patients reported ≥1 adverse event during the open-label phase, and 29.8% of patients reported ≥1 adverse event during the double-blind phase. The reported events were consistent with the safety profile of other extended-release amphetamines. There were no reports of suicidality on the C-SSRS during any phase of the study.
Overall, a significant treatment difference in change from pre-dose SKAMP-Combined score was seen at the primary endpoint of 4 hours post-dose and at each post-dose time point assessed. Onset of action was seen at 1 hour post-dose with treatment effect lasting to 13 hours post-dose.