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Dasotraline improves ADHD in children
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Dasotraline, a dopamine and norepinephrine reuptake inhibitor, improved ADHD symptoms in children aged 6 to 12 years, according to study findings announced by Sunovion Pharmaceuticals.
“We are encouraged that dasotraline has demonstrated in this study the potential to help children with ADHD,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in a press release. “We recognize that there are still significant gaps in the treatment of ADHD, particularly a need for products that provide sustained therapeutic effects. We look forward to the overall results of the dasotraline development program, which is evaluating this potential therapy in children and adults with ADHD.”
To assess efficacy and safety of dasotraline for ADHD, researchers conducted a phase 2/phase 3, randomized, double-blind, multi-center, placebo-controlled, parallel-group, fixed dose trial among 342 children aged 6 to 12 years with ADHD. Study participants received 2 mg or 4 mg of dasotraline per day. The primary efficacy endpoint was change from baseline to week 6 in ADHD Rating Scale-IV: Home Version total score.
Compared with placebo, participants who received 4 mg of dasotraline exhibited statistically significant and clinically relevant differences in ADHD scores, whereas those who received 2 mg did not.
Dasotraline was generally well-tolerated, according to the release. The most common treatment-emergent adverse events were insomnia, decreased appetite and decreased weight.
Overall, 9.3% of participants who received dasotraline discontinued due to treatment-emergent adverse events.
Dasotraline is also being studied for binge-eating disorder in adults.