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Dasotraline improves ADHD outcomes in the classroom
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Recent findings indicated dasotraline, a dopamine and norepinephrine reuptake inhibitor, significantly improved ADHD outcomes in the classroom among children aged 6 to 12 years.
“ADHD symptoms can have a significant impact on all aspects of a child’s life, inside and outside of the classroom,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, said in a press release. “Treatment options that provide sustained improvement in ADHD symptoms throughout the day can have a profound effect on the lives of children living with ADHD and their parents or caregivers.”
To assess effects of dasotraline (Sunovion Pharmaceuticals Inc.) for ADHD in a classroom setting, researchers conducted a phase 3, 2-week, randomized, double-blind, multicenter, placebo-controlled, fixed-dose study among 112 children, aged 6 to 12 years, with ADHD. Study participants received 4 mg of dasotraline or placebo once daily. An average of seven assessments were collected across a 12-hour classroom day, which occurred 12 to 24 hours’ post-dose.
From baseline to day 15, mean change in Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale Combined Scores (SKAMP-CS) was –3.19 (95% CI, –5.06 to –1.32) for participants who received dasotraline, compared with 1.99 (95% CI, 0.11-3.88) among those who received placebo (P < .0001).
At day 15, mean changes in SKAMP subscales for attention (–0.67; 95% CI, –1.22 to –0.11; P < .0001) and deportment (–1.44; 95% CI, –2.14 to –0.75; P .0006) were statistically significantly improved among participants who received dasotraline, compared with placebo.
Permanent Product Measure of Performance scale scores, which assessed attention and performance via math problems, also significantly improved among the dasotraline group.
The most common treatment-emergent adverse events were insomnia, decreased appetite, affect lability, headache and irritability.
The 4-mg dosage of dasotraline was generally well-tolerated, according to researchers.
“We are encouraged by these data showing the long-acting and robust therapeutic benefits dasotraline may provide children with ADHD,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in the release. “These results add to our body of knowledge about dasotraline and reinforce its potential as a treatment option poised to address significant gaps in available treatment.”