FRIDAY, March 8, 2019 — Treatment with dasotraline (4 mg/day) significantly improves attention-deficit/hyperactivity disorder (ADHD) symptoms in children aged 6 to 12 years, according to a study published online March 7 in the Journal of Child and Adolescent Psychopharmacology.
Robert L. Findling, M.D., from Johns Hopkins University in Baltimore, and colleagues randomly assigned 342 children diagnosed with ADHD (mean age, 9.1 years; 66.7 percent male) to six weeks of once-daily treatment with either dasotraline (2 or 4 mg) or placebo.
The researchers found that treatment with dasotraline 4 mg/day was associated with significant improvement in the ADHD Rating Scale Version IV-Home Version total score versus placebo, but the 2-mg/day dose was not. The dasotraline 4-mg/day dose was also associated with significant improvement versus placebo for the Clinical Global Impression-Severity scale, the Conners’ Parent Rating Scale-Revised ADHD index score, and subscale measures of hyperactivity and inattentiveness. However, the dasotraline 4-mg/day group had higher discontinuation rates due to adverse events compared with the 2-mg/day group (12.2 and 6.3 percent, respectively, versus 1.7 percent for placebo). Insomnia, decreased appetite, decreased weight, and irritability were the most common adverse events associated with dasotraline. Psychosis-related symptoms were reported by seven of 219 patients taking dasotraline.
“The results of the current study provide efficacy and safety data indicating that dasotraline, dosed once-per-day, is a promising therapeutic option for the treatment of ADHD, with a reduced potential for abuse, and with a long elimination half-life permitting sustained efficacy across a 24-hour dosing interval,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Sunovion, which manufactures dasotraline and funded the study.
Posted: March 2019
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