Journal Frontiers in Psychiatry Publishes Analysis of Open Label Safety Study Showing Improvements in Sleep Habits for Children With ADHD After Treatment With AZSTARYS® (serdexmethylphenidate and dexmethylphenidate)
BOSTON, June 26, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today that the peer-reviewed journal Frontiers in Psychiatry published an analysis of a yearlong open-label safety study of Corium's attention-deficit hyperactivity disorder (ADHD) medicine AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]). AZSTARYS was approved by the U.S. Food and Drug Administration in 2021 for the treatment of ADHD symptoms in people aged 6 years through adulthood. The analysis showed that study participants, children aged 6 to 12 years with ADHD and treated with AZSTARYS for up to twelve months, had statistically significant and lasting improvements in their sleep as assessed by the Children's Sleep Habits Questionnaire (CSHQ), a caregiver-reported screening survey designed to assess behavioral and medically based sleep problems in school children.
- AZSTARYS was approved by the U.S. Food and Drug Administration in 2021 for the treatment of ADHD symptoms in people aged 6 years through adulthood.
- Almost three in four children with ADHD have some sleep impairment, according to Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), a national nonprofit organization serving people affected by ADHD.
- After one month of AZSTARYS treatment, the children's average CSHQ total sleep disturbance score significantly decreased, indicating improved sleep.
- Moreover, after 12 months of treatment their average CSHQ total score remained in the 48.9 to 50.1 range, indicating the children sustained overall sleep improvements while receiving AZSTARYS.