Phase III study of dasotraline shows significant improvement in children with ADHD- Sunovion Pharma

Sunovion Pharmaceuticals announced positive results of a pivotal Phase III study (SEP360-305) evaluating the efficacy and safety of dasotraline being evaluated in children six to 12 years of age with attention deficit hyperactivity disorder (ADHD). In a laboratory classroom setting, dasotraline showed persistent, statistically significant improvement in ADHD symptoms compared to placebo throughout the day (12 to 24 hours post-dose), demonstrating a duration of effect of up to 24 hours, and was generally well tolerated.

In this study, children six to 12 years of age with ADHD taking dasotraline 4 mg/day experienced statistically significant and clinically meaningful improvement compared to placebo on the primary endpoint, change from baseline at Day 15 in ADHD symptoms as measured by mean Swanson, Kotkin, Agler, M-Flynn and Pelham Scale Combined Score (SKAMP-CS) obtained from an average of seven assessments collected over the 12-hour classroom day, 12 to 24 hours post-dose (least squares [LS] mean change from baseline at Day 15. Dasotraline demonstrated statistically significant improvement compared to placebo on multiple secondary endpoints, including SKAMP subscales measuring attention (least squares [LS] mean change from baseline at Day 15. Dasotraline 4 mg/day was generally well tolerated with an adverse event (AE) profile consistent with completed studies in children and adults. The full study results were presented in a poster session at the 6th World Congress on ADHD.

Sunovion plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in fiscal year 2017 (April 2017-March 2018) for the treatment of ADHD. Dasotraline is also being investigated for the treatment of binge eating disorder (BED) in adults in the U.S.