Improvement in ADHD Symptoms Observed in Dasotraline Trial

Sunovion announced positive results from the first placebo-controlled clinical trial of dasotraline for the treatment of adults with attention deficit hyperactivity disorder (ADHD). Dasotraline inhibits the pre-synaptic reuptake of dopamine and norepinephrine.

The study is a four-week, double-blind, randomized, placebo-controlled clinical trial in adults with ADHD. Participants were randomized to dasotraline 4mg/day, dasotraline 8mg/day or placebo. Dasotraline 8mg/day demonstrated statistically significant improvement in symptoms of ADHD compared to placebo as measured by the ADHD Rating Scale-Version IV (RS-IV) total score (LS mean -13.9 vs. -9.7; p=0.019), the primary efficacy endpoint of the study, and the inattentiveness (LS mean -8.0 vs. -5.6; p=0.016) and hyperactivity/impulsivity (LS mean -5.9 vs. -4.1; p=0.027) subscale scores. The dasotraline 4mg/day dose was associated with improvement on the ADHD RS-IV total (LS mean -12.4 vs. -9.7; p=0.076) and subscale scores compared to placebo.

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The results from the first study and the recently initiated second study are intended to support a future New Drug Application (NDA) in this patient population. Sunovion also intends to initiate a clinical development program to assess the safety and efficacy of dasotraline in pediatric patients with ADHD.

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