Dasotraline Improves ADHD Symptoms in Children in Phase 3 Trial
Dasotraline, a dopamine and norepinephrine reuptake inhibitor (DNRI), significantly improved symptoms of attention-deficit/hyperactivity disorder (ADHD) in children for up to 24 hours in a Phase 3 study, Sunovion Pharmaceuticals announced.
The 2-week, randomized, double-blind study involved 112 children 6 to 12 years of age with ADHD tested in laboratory classroom settings. Results were presented at the 6th World Congress on ADHD, held April 20-23, 2017, in Vancouver, Canada.
Sunovion plans to submit a New Drug Application to the US Food and Drug Administration (FDA) in fiscal year 2017 (April 2017-March 2018) for the treatment of ADHD. The drug is also being investigated as a treatment of binge eating disorder in adults.
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Participants in the study took 4 mg/day of dasotraline. Compared with placebo, they “experienced statistically significant and clinically meaningful improvement” in ADHD symptoms over 15 days, according to Sunovion.
The participants were assessed 7 times over the 12-hour classroom day, which was 12 to 24 hours after taking the medication. The treatment group “maintained significant separation from placebo” during that time, “supporting up to 24-hour duration of effect,” Sunovion said in a statement. Dasotraline was also associated with statistically significant improvement, compared with placebo, in attention, deportment, and the number of attempted and completed math problems.
Sunovion reported the drug was “generally well tolerated.” Side effects that were more common in the treatment group than in the placebo group, and reported in 5 percent or more of patients, included insomnia, decreased appetite, rapid change in emotion, headache, and irritability.
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Dasotraline is a new chemical entity which Sunovion said has shown, in clinical testing, a lower potential for abuse than methylphenidate. It has not yet received any FDA approvals.
“We are encouraged by these data showing the long-acting and robust therapeutic benefits dasotraline may provide children with ADHD,” said Antony Loebel, MD, executive vice president and Chief Medical Officer at Sunovion, head of global clinical development for Sumitomo Dainippon Pharma Group. “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.”
—Terri Airov
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