Azstarys outperforms placebo for improving ADHD symptoms in children
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Azstarys significantly improved ADHD symptoms in children aged 6 to 12 years vs. placebo, according to results of a randomized, controlled laboratory classroom study published in Journal of Child and Adolescent Psychopharmacology.
“There remains a significant unmet need for more effective and safe medications to treat ADHD, especially medicines with early onset of action and duration throughout the day,” study co-author Andrew Cutler, MD, chief medical officer at Neuroscience Education Institute and a clinical associate professor of psychiatry at SUNY Upstate Medical University, told Healio Psychiatry. “Many extended-release stimulant preparations wear off too soon, leaving clinicians to add an immediate release preparation to cover the later part of the day.
“The unique combination of serdexmethylphenidate (SDX), a prodrug of d-methylphenidate, and immediate release d-methylphenidate (d-MPH) was formulated to address this need,” Cutler added. “While there is a prodrug form of amphetamine, until now there was not a methylphenidate prodrug approved.”
Cutler and colleagues sought to examine the efficacy and safety of once-daily Azstarys (serdexmethylphenidate and dexmethylphenidate [SDX/d-MPH]; Corium) vs. placebo among 149 children with ADHD aged 6 to 12 years. Participants received 39.2 mg/7.8 mg per day of SDX/d-MPH and were titrated weekly to an optimal dose, up to 52.3 mg/10.4mg, during a 3-week, open-label dose optimization phase. In a double-blind treatment phase, the researchers randomly assigned participants to their optimal dose of SDX-d-MPH or placebo for 7 days. They assessed efficacy on day 7 in the laboratory classroom via the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP). They examined adverse events, vital signs, electrocardiograms and suicide risk to determine safety.
Results of the primary efficacy analysis showed SDX/d-MPH correlated with significant improvement in mean post-dose change from baseline in SKAMP-Combined scores averaged over the laboratory classroom day compared with placebo (least-squares mean treatment difference = -5.41; 95% CI, -7.1 to -3.71). Between 1 to 10 hours post-dose, the researchers observed a significant treatment effect for SDX/d-MPH vs. placebo.
Results of a post-hoc analysis more aligned with that conducted in similar studies showed a 0.5- to 13-hour onset and duration of efficacy, according to Cutler and colleagues. Participants treated with SDX/d-MPH vs. placebo exhibited significant improvement in both average post-dose PERMP-Attempted and PERMP-Correct score changes from baseline (P < 0.001 for both). Participants reported no serious adverse events; however, during the dose optimization phase, two-thirds reported adverse events, with insomnia and decreased appetite as the most common.
“Utilizing the unique laboratory classroom design, this study demonstrated efficacy of this medication as soon as 30 minutes after administration, and lasting up to 13 hours,” Cutler said. “It was also well-tolerated with adverse events similar to those seen with other methylphenidate preparations and no new safety findings.
“This study supported the FDA approval of SDX/d-MPH for the treatment of ADHD in patients 6 years or older, and it is now available for clinicians to prescribe to help their patients and families treat the impairing symptoms of ADHD,” Cutler added.