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First new prodrug of dexmethylphenidate for Children with ADHD

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Corium, Inc. announced that its poster, “Serdexmethylphenidate/d-Methylphenidate Capsules for Children With ADHD: Effects on SKAMP-C Evaluated Over 13 Hours in a Randomized, Double-blind, Placebo-controlled Laboratory Classroom Study,” will be presented at the Academy of Managed Care Pharmacy (AMCP) on March 30, 2022, in Chicago, IL. Corium’s once-daily oral capsule AZSTARYS (serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)), significantly improved both attention and behavior with a 30-minute onset and up to 13 hours of duration in children ages 6 to 12 years diagnosed with attention deficit hyperactivity disorder (ADHD), compared to a placebo. An author will report the findings (poster # F21), from a post hoc analysis of a pivotal Phase 3 study, at the AMCP.

The U.S. Food and Drug Administration (FDA) approved AZSTARYS as a once-daily treatment of ADHD symptoms in patients aged 6 years and older on March 2, 2021. AZSTARYS is the first and only medicine containing SDX, a prodrug of d-MPH, which provides for an extended duration of d-MPH release throughout the day. Once-daily AZSTARYS is available nationally in the U.S. in three SDX/immediate-release d-MPH dose strengths of 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg.

“This analysis of data previously collected in a pivotal trial demonstrates that the fast onset and long duration of AZSTARYS delivers early and prolonged efficacy to manage attention and behavior throughout the treatment day of patients with ADHD. These results offer patients, parents, and healthcare professionals valuable information to consider when choosing among proven ADHD treatments. We appreciate the opportunity to share this data at the AMCP,” said Charles Oh, MD, Chief Medical Officer of Corium.

The findings are from an evaluation of the participants in a placebo-controlled laboratory classroom study (NCT03292952), based on their scores on the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale – Combined (SKAMP-C). The SKAMP-C is a validated measure of classroom behaviors in children with ADHD, with lower scores representing improvement and a reduction of ADHD symptoms. The children, whose average age was 9.6 years, took the SKAMP-C before receiving AZSTARYS or the placebo and then eight times after dosing, starting at 30 minutes and then at hours 1, 2, 4, 8, 10, 12 and 13.

The primary efficacy measure in the trial was the average change in the SKAMP-C score from before dosing and then at multiple times during the classroom day. The post hoc analysis was conducted to align the data with other MPH clinical trial designs, which have used the morning of the classroom day, or an analogous study visit, as the baseline for pre-medication SKAMP-C scores.

The average changes in SKAMP-C scores averaged across all time measures were significantly improved by -5.41 points (p<0.001) for participants receiving AZSTARYS compared to those receiving the placebo, with respective score changes of -4.87 vs. 0.54. Similarly, the SKAMP-C scores in the post hoc analysis showed significant improvement for children treated with AZSTARYS compared with the placebo group. The onset of treatment effect began at 30 minutes after dosing, with a significant score difference of -3.97 between groups (P<0.001), and continued for 13 hours after dosing, with a significant score difference of -3.49 (P=0.004).

Investigators reported no serious adverse events (AEs) in the study. Reported AEs were typical of methylphenidate treatment, and the majority were rated as mild to moderate in severity. Those AEs occurring more frequently in the ASZTARYS group (in 2 percent or more of the participants) compared to the placebo group were headache (5.4 vs. 1.3 percent, AZSTARYS and placebo respectively), upper abdominal pain (4.1 vs. 1.3 percent), insomnia (2.7 vs. 1.3 percent), and pharyngitis (sore throat) (2.7 vs. 0 percent).

The trial enrolled 155 children aged 6 to 12 years in a three-week, open-label dose optimization phase. Of those children, 150 were randomized to a seven-day, double-blind, placebo-controlled treatment period.

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