CHICAGO — A long-acting formulation of dexmethylphenidate is safe and effective in children and adolescents with attention-deficit hyperactivity disorder, according to data presented at the annual meeting of the Society for Developmental and Behavioral Pediatrics.
Children taking the investigational treatment showed improvements in core symptoms both at school and at home, compared with patients taking placebo.
The treatment, currently known as dexmethylphenidate extended-release capsules (d-MPH-ER), is a once-daily formulation of Focalin, which was introduced in 2002. D-MPH-ER is in phase III trials.
Focalin and d-MPH-ER contain only the active isomer of racemic methylphenidate (Ritalin), said lead investigator Frank Lopez, M.D., of Children's Developmental Center, Maitland, Fla. “You get twice the effect at half the amount in terms of what you are delivering,” Dr. Lopez said during the poster presentation.
Sustained medications are often preferable to immediate-release drugs because they improve compliance and decrease the stigma of having to take medications at school.
In the double-blind, parallel-group study, 103 patients (aged 6–17 years) with a previous diagnosis of ADHD of any type were randomized to receive d-MPH-ER 5–30 mg or placebo once daily for 7 weeks. A flexible dosing schedule was used during weeks 1 through 5 to determine optimal therapeutic levels, and patients were then maintained on their optimal dosages for the remaining 2 weeks.
A total of 97 patients were evaluated for efficacy, and a total of 100 patients were evaluated for safety, he said. The primary efficacy end point was change from baseline to final visit in the total subscale score of the Conners ADHD/DSM-IV Scale for Teachers (CADS-T).
At the final visit, scores on all primary and secondary efficacy end points, except the Child Health Questionnaire physical component score, were statistically superior for d-MPH-ER, compared with placebo. The differences between groups emerged early and increased over time.
The adjusted mean change from baseline to final visit in the CADS-T total score was 16.3 in the d-MPH-ER group vs. 5.7 in the placebo group. The adjusted mean change in the CADS for Parents (CADS-P) total subscale scores from baseline was 17.6 in the d-MPH-ER group vs. 6.5 in the placebo group.
Overall, 67% of patients treated with d-MPH-ER were rated as “very much improved” or “much improved” on the Clinical Global Impressions-Improvement (CGI-I) scale at the final visit, compared with 13% of patients in the placebo group.
Of d-MPH-ER patients, 49% reported an adverse event, compared with 26% in the placebo group. The most frequently reported adverse events associated with d-MPH-ER were decreased appetite (28%), headache (9%), and insomnia (7%).