Sunovion announced positive Phase 3 study data (SEP360-305) for dasotraline being evaluated in patients aged 6–12 years with attention deficit hyperactivity disorder (ADHD). The findings were presented at the 6th World Congress on ADHD in Vancouver, Canada.

The SEP360-305 study (n=112) was a 2-week, randomized, double-blind, multi-center, placebo-controlled fixed-dose study that compared dasotraline vs. placebo in children aged 6–12 years with ADHD. The primary endpoint was the change from baseline at Day 15 in ADHD symptoms as measured by the mean SKAMP-CS taken from an average of seven assessments across a 12-hr classroom day (12–24hrs post-dose) vs. the placebo group. 

Study data revealed children taking dasotraline 4mg daily had statistically significant and clinically meaningful improvement vs. placebo on the primary endpoint (least squares mean change from baseline at Day 15: –3.19 [95% CI: –5.06, –1.32] vs. 1.99 [95% CI: 0.11, 3.88]; P<0.0001). The 24-hr duration of effect was sustained with dasotraline showing a significant separation from placebo on the SKAMP-CS over time (12–24hrs post-dose). 

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Dasotraline further demonstrated statistically significant improvement vs. placebo on various secondary endpoints, including SKAMP subscales measuring attention and deportment. A significant improvement on the Permanent Product Measure of Performance (PERMP) scale measuring attention and performance based on attempted and completed math problems was also seen.

Dasotraline is an investigational dopamine and norepinephrine reuptake inhibitor (DNRI). Its extended half-life supports a continuous therapeutic effect over the 24-hr dosing interval. Moreover, it has shown a lower potential for abuse vs. methylphenidate in clinical testing.

A New Drug Application (NDA) will be submitted to the Food and Drug Administration (FDA) between April 2017–March 2018 for the treatment of ADHD. Dasotraline is also being evaluated as a potential treatment for binge eating disorder (BED) in adults. 

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