Corium (NSDQ:CORI) today announced clinical data demonstrating the strong performance of its once-daily ADHD capsule.
Boston-based Corium’s Azstarys oral capsule for treating ADHD symptoms (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) received FDA approval in March as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients aged six years and older.
Results from a phase 3 controlled classroom clinical trial, set to be presented tomorrow during the American Psychiatric Nurses Association (APNA) 35th Annual Conference, showed that Azstarys significantly reduced ADHD symptoms in children ages 6-12 years old.
Investigators randomized 150 children to receive Azstarys or placebo during a seven-day, double-blind treatment period that followed a three-week dose-optimization phase, according to a news release.
The primary efficacy endpoint was the mean change in the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale – Combined (SKAMP-C) during the classroom day. Results found that the SKAMP-C was significantly lower (indicating improvement) with Azstarys compared to placebo (mean change of -4.87 vs. 0.54, respectively).
Azstarys also demonstrated improvements in ADHD symptoms measured by a secondary efficacy endpoint, the Weekly Rating of Evening and Morning Behavior – Revised (WREMB-R). The mean change from baseline in WREMB-R scores for Azstarys vs. placebo were -11.7 vs. -7.2.
The trial observed no serious adverse events, deaths or overdoses in the study. The majority of treatment-affected adverse events were graded as mild or moderate, with such events proving similar to those reported for approved methylphenidate drugs.
“The clinical data from the classroom study demonstrate that the first medicine to combine the innovative d-MPH prodrug with d-MPH can safely and effectively improve ADHD symptoms in children,” President of the Center for Psychiatry and Behavioral Medicine and investigator in the Azstarys clinical trial Dr. Ann Childress said in the release. “Azstarys gives parents and clinicians another option when seeking an ADHD therapy for children.”