Sunovion Pharmaceuticals announced positive results of a pivotal phase III study (SEP360-305) evaluating the efficacy and safety of novel drug candidate dasotraline, a dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated in children 6 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.

The full study results were presented in a poster session today at the 6th World Congress on ADHD, being held April 20-23, 2017, in Vancouver, Canada.

“ADHD symptoms can have a significant impact on all aspects of a child’s life, inside and outside of the classroom,” said Ann C. Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada. “Treatment options that provide sustained improvement in ADHD symptoms throughout the day can have a profound effect on the lives of children living with ADHD and their parents or caregivers.”

Sunovion plans to submit a New Drug Application (NDA) to the 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.

“We are encouraged by these data showing the long-acting and robust therapeutic benefits dasotraline may provide children with ADHD,” said Antony Loebel, M.D., 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.”

In this study, children 6 to 12 years of age with ADHD taking dasotraline 4mg/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: -3.19 [95% CI: -5.06, -1.32] vs 1.99 [0.11, 3.88], respectively; effect size (ES)=0.85, p<0.0001). Dasotraline maintained significant separation from placebo on the SKAMP-CS over time, 12 to 24 hours post-dose, supporting up to 24-hour duration of effect.

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: -0.67 [95% CI: -1.22, -0.11] vs 0.79 [0.23, 1.35], respectively; effect size (ES)=0.81, p<0.0001) and deportment (least squares [LS] mean change from baseline at day 15: -1.44 [95% CI: -2.14, -0.75] vs 0.16 [-0.55, 0.86], respectively; effect size (ES)=0.70, p≤0.0006). Statistically significant improvement was also seen on the Permanent Product Measure of Performance (PERMP) scale measuring attention and performance based on the number of attempted and completed math problems.

Dasotraline 4mg/day was generally well-tolerated with an adverse event (AE) profile consistent with completed studies in children and adults. The most common treatment-emergent adverse events (TEAEs) (reported in 5% or more of patients and greater than placebo) included insomnia, decreased appetite, affect lability (rapid change in emotion), headache and irritability.