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Dasotraline effective for ADHD in children
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Sunovion Pharmaceuticals recently announced dasotraline, a dopamine and norepinephrine reuptake inhibitor, significantly improved ADHD in children aged 6 to 12 years.
To assess efficacy of dasotraline for ADHD in children, researchers conducted a phase 2/phase 3, randomized, double-blind, multi-center, placebo-controlled, parallel-group efficacy and safety trial among 342 children aged 6 to 12 years with a primary diagnosis of ADHD. Study participants were randomly assigned to received 2 mg (n = 111) or 4 mg (n = 115) of dasotraline or placebo (n = 116) per day for 6 weeks. Participants who received the 4-mg dose initiated with 2 mg of dasotraline per day for the first week and increased to 4 mg at week 2.
From baseline to week 6, children who received 4 mg of dasotraline daily exhibited statistically significant improvement in ADHD Rating Scale IV: Home Version total scores (–17.53; 95% CI, –20.12 to –14.95; P < .001), compared with placebo (–11.36; 95% CI, –13.89 to – 8.83).
Statistically significant improvement was maintained each week through week 6.
Children who received 4 mg of dasotraline also exhibited significant improvement in Clinical Global Impression-Severity of Illness Scale scores, compared with placebo.
There were no statistically significant differences in ADHD outcomes for 2 mg of dasotraline or placebo.
Both dosages of dasotraline were generally well-tolerated, according to researchers. The most common treatment-related adverse events included insomnia, decreased appetite and decreased weight.
Upon successful completion of ongoing studies and discussions with the FDA, Sunovion intends to submit a New Drug Application for dasotraline for ADHD among children and adults in 2017.
“Sunovion is dedicated to advancing the treatment of serious neuropsychiatric conditions, such as ADHD,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in a press release. “These study results are encouraging and support the efficacy and safety of dasotraline for the treatment of ADHD.”