A six-week, combined phase trial of the novel drug candidate dasotraline by Sunovion Pharmaceuticals Inc. found it was generally well-tolerated and demonstrated a statistically significant difference compared to placebo when given to children with attention-deficit/hyperactivity disorder.
The Marlborough drugmaker administered once-daily doses of dasotraline to 342 children ages 6-12. Children given doses of four milligrams per deciliter of dasotraline saw statistically significant, clinically relevant results, according to Sunovion. Just over 9 percent of participants discontinued the study due to treatment-emergent adverse effects, including insomnia, decreased appetite and weight loss.
“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,” said Antony Loebel, executive vice president and chief medical officer at Sunovion and head of global clinical development for Sumitomo Dainippon Pharma Group.
