SDX/d-MPH safe and effective against pediatric ADHD

Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH; Azstarys; KemPharm) is safe and efficient for treating attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 or more years, according to a recent study.

The open-label safety study, occurring from February 21, 2018, to June 27, 2019, measured the safety and efficacy of oral SDX/d-MPH in children aged 6 to 12 years with ADHD. Participants from a placebo-controlled laboratory classroom study were rolled over into the study, while new subjects were also recruited.

Participants included were in good health, with new participants weighing at least 21 kg at screening. ADHD diagnosis for new participants was measured through Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. 

Exclusion criteria included diagnosis of bipolar 1 or 2 disorder, conduct disorder, major depressive disorder, and obsessive-compulsive disorder. Patients with a history of psychosis, disruptive mood dysregulation disorder, autism spectrum disorder, Tourette syndrome,intellectual disability, or genetic disorder affecting behavior were also excluded.

A 30-day screening phase, a dose optimization (DO) phase,a 360-day treatment phase, and a follow-up visit made up the study, with participants from the laboratory classroom study bypassing the screening and DO phases. The best dose for new patients was measured based on tolerability in the DO phase.

A safety population, made up of participants who took at least 1 dose of study medication and had 1 or more safety assessments after receiving their dose, were used to gather baseline and safety data. Follow-up visits took place about 3 days after taking the final dose.

At screening, 6 months of treatment, and the end of the treatment phase, participants underwent clinical laboratory assessments, physical examinations, and electrocardiograms, while vital signs were assessed during each study visit.

An efficacy population, consisting of participants receiving study medication for 30 days or more during the treatment phase, was used to collect efficacy data. The ADHD Rating Scale-5 (ADHD-RS-5), Clinical Global Impressions–Severity scale (CGI-S), and Clinical Global Impressions–Improvement scale measured ADHD symptoms and severity in participants.

There were 282 participants included in the study, 70 rollover and 212 new. Of these, 155 completed treatment. Subjects had a mean age of 9.1 years, and 61% were male, 19% Hispanic or Latino, 48% White, and 47% Black.

Treatment-emergent adverse events (TEAEs) were seen in 54.3% of participants during the DO phase, with the most common TEAEs being decreased appetite in 18.8% of participants, insomnia in 6.7%, irritability in 6.7%, and initial insomnia in 5.3%.

During the treatment phase, 1 or more TEAE was seen in 60.1% of patients, with 15.1% experiencing mild TEAEs, 39.9% moderate TEAEs, and 5% severe TEAEs. Decreased appetite was seen in 18.5% of patients, upper respiratory tract infection in 9.7%, nasopharyngitis in 8%, decreased weight in 7.6%, and irritability in 6.7%. There were no reported life-threatening or fatal TEAEs.

The mean ADHD-RS-5 score was 41.5 at baseline, while the mean CGI-S score was 4.7. After 1 month of treatment, the mean ADHD-RS-5 score decreased to 16.1, while the CGI-S score decreased to 2.5. This indicated significant improvement in the clinical severity of ADHD.

Reference

Childress AC, Marraffino A, Cutler AJ, Oh C, Brams MN. Safety and tolerability of serdexmethylphenidate/dexmethylphenidate capsules in children with attention-deficit/hyperactivity disorder: a 12-Month, open-label safety study. Journal of Child and Adolescent Psychopharmacology. 2023. doi:10.1089/cap.2022.0076