Azstarys found to be well-tolerated with few adverse events in children with ADHD
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Azstarys had a favorable safety profile, demonstrated efficacy and was well-tolerated compared to other methylphenidate products over 1 year of treatment, according to research presented in the Journal of Child and Adolescent Psychopharmacology.
“Azstarys is the only extended release dexmethylphenidate product that contains an immediate-release dexmethylphenidate prodrug on the market,” Ann C. Childress, MD, of the Center for Psychiatry and Behavioral Medicine in Las Vegas, told Healio. “It may be useful for patients who require a medication that shows efficacy early in the day and continued effects into the evening.”
Childress and colleagues sought to assess safety and tolerability of daily administration of Azstarys (serdexmethylphenidate/dexmethylphenidate, Corium) for a period lasting until 1 year in a pediatric population with ADHD.
The dose-optimized, open-label safety study was conducted at 18 sites in the United States between February 2018 and June 2019 and included 282 individuals (70 from a previous double-blind study, 212 new participants) aged 6 to 12 years who were diagnosed with ADHD. The trial was composed of a 30-day screening phase, dose optimization phase and follow-ups. For rollover and new participants, initial dose of the drug could be changed based upon response and tolerability, During dose optimization, new participants began treatment with 39.2/7.8 mg of SDX/d-MPH per day for 7 days, with adjustments made roughly on a weekly basis. In the dose optimization phase, adjustments were guided by ADHD Rating Scale-5 and Clinical Global Impressions Improvement scale scores.
Adverse events were tracked from treatment initiation through treatment completion. All participants underwent a follow-up visit approximately 3 days after receiving their final dose.
A total of 127 participants discontinued, leaving 155 participants who completed the study. Of 238 subjects assessed in the treatment-phase safety population, 5% (12) experienced severe adverse events, with the most common adverse events being decreased appetite (18.5%), upper respiratory tract infection (9.7%) and nasopharyngitis (8%).
Researchers also found the treatment led to overall reductions in ADHD symptoms and severity as assessed by ADHD-RS-5 and CGI-S during the treatment phase.
“Safety was comparable to other methylphenidate products, and no unexpected adverse effects were noted,” Childress told Healio.