www.fdanews.com/articles/178622-sunovions-dasotraline-achieves-primary-endpoint-in-childhood-adhd
Sunovion’s Dasotraline Achieves Primary Endpoint in Childhood ADHD
September 28, 2016
A Phase II/III study of once-daily dasotraline in children ages 6 to 12 with attention deficit hyperactivity disorder met its primary endpoint, demonstrating significant changes in a home ADHD rating scale compared to placebo.
The six-week study compared 4 mg and 2 mg doses in 342 children; the 2 mg dose did not produce statistically significant results. Dasotraline was generally well tolerated.
Developed by Sunovion Pharmaceuticals, dasotraline is also being studied as a treatment for binge eating disorder. The company plans to present full study results at an upcoming scientific meeting.