Improvement in sleep domain scores was statistically significant and observed throughout the twelve-month study.
New data shows that children with attention-deficit hyperactivity disorder (ADHD), after one month of taking AZSTARYS, had statistically significant improvement in their sleep as assessed by the Children’s Sleep Habits Questionnaire (CSHQ). The improvement in sleep was sustained through 12 months of treatment with AZSTARYS.
Biopharmaceutical company Corium announced the publication of the results in a poster, “Serdexmethylphenidate/Dexmethylphenidate Effects on Sleep in Children With Attention-Deficit Hyperactivity Disorder,” at the Psych Congress 2022 in New Orleans.
The poster presented an analysis of the twelve-month open-label safety study in children ages 6-12 using AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which is indicated for the treatment of ADHD in patients six and older.
The data showed that the children, after one month of taking AZSTARYS, had statistically significant improvement in their sleep as assessed by the Children’s Sleep Habits Questionnaire (CSHQ). The improvement in sleep was sustained through 12 months of treatment with AZSTARYS.
AZSTARYS, a central nervous system (CNS) stimulant designated a Schedule II controlled substance, is the first and only medicine for ADHD symptoms containing SDX, the prodrug of d-MPH, along with immediate-release d-MPH. SDX is designed specifically to be pharmacologically inactive until reaching a patient’s lower gastrointestinal (GI) tract, where, by design, the prodrug gradually converts to d-MPH throughout the day.
This formulation provides control of ADHD symptoms rapidly with the immediate-release d-MPH and for an extended duration with SDX. Once-daily AZSTARYS is available in the U.S. in three SDX/d-MPH dose strengths of 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg. The SDX component of AZSTARYS is designated a Schedule IV controlled substance.
After one month of taking AZSTARYS, children with ADHD had statistically significant improvement in their sleep.
“Sleep-related problems are common in children with ADHD, which some stimulant medications can negatively impact. The positive study data reported provide important and relevant information to healthcare professionals considering AZSTARYS,” says Greg W. Mattingly, lead author of the poster, associate clinical professor of psychiatry at Washington University School of Medicine, and president-elect of the American Professional Society for ADHD and Related Disorders, in a statement.
“These data show how existing sleep problems in children with ADHD improved when treated with AZSTARYS during the study,” says Charles Oh, MD, chief medical officer of Corium, in a statement. “Presenting these AZSTARYS findings at Psych Congress 2022 is another milestone in Corium’s ongoing activities to lead in the CNS therapeutic space.”
About the Open Label Safety Trial
The one-year dose-optimized open-label study enrolled 282 children aged 6 to 12 years at 19 locations. The participants included 70 children who participated within the previous 45 days in a prior double-blind AZSTARYS classroom study and 212 new children. After a 30-day screening phase and a three-week dose-optimization phase for new participants, the children received treatment with AZSTARYS for one year.
Optimized AZSTARYS doses included 26.1/5.2 milligrams (mg), 39.2/7.8 mg, or 52.3/10.4 mg of SDX/d-MPH daily, which delivered 20-, 30-, and 40-mg molar equivalent doses of total d-MPH HCl. The Children’s Sleep Habits Questionnaire (CSHQ) was a pre-specified secondary endpoint that evaluated sleep parameters. The sleep assessment included data from 238 children.
After one month of AZSTARYS treatment in the open-label classroom study, the children’s total average sleep disturbance score on the CSHQ significantly decreased, indicating overall improvements in their sleep behavior. Specifically, their scores decreased from 53.4 (±5.9 standard deviation [SD]) at the study start to 50.5 (±5.4) at one month, a least-squares mean change from baseline of −2.9 points (95% CI: −3.5 to −2.4; P < .0001). Moreover, their total mean CSHQ scores remained in a range of 48.9 to 50.1 points for up to 12 months, indicating sustained overall sleep improvement from baseline.