Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Sunovion Pharmaceuticals (Sunovion) announced positive results from the first placebo-controlled clinical study of the company’s investigational drug dasotraline for the treatment of adult patients with attention deficit hyperactivity disorder (ADHD).
Subscribe to our email newsletter
The findings were presented at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) held December 7-11 in Phoenix, Arizona.
Dasotraline, a new chemical entity discovered by Sunovion, inhibits the pre-synaptic reuptake of dopamine and norepinephrine. In the 4-week, double-blind, randomized, placebo-controlled clinical trial, adults with ADHD were randomized to dasotraline 4 mg/day, dasotraline 8 mg/day or placebo.
"ADHD symptoms, such as restlessness, impulsiveness and inattention, can disrupt patients’ lives and adversely impact work, family and social functioning," said Scott H. Kollins, Ph.D., Professor in the Department of Psychiatry & Behavioral Science, Duke University School of Medicine, and a lead investigator of the study.
"It is important to continue to study novel therapeutic options that have the potential to help patients manage their ADHD symptoms and improve overall functioning."
Dasotraline 8 mg/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 4 mg/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. Both dasotraline 4 mg/day (LS mean -1.1 vs. -0.7; p=0.021) and 8 mg/day (LS mean -1.1 vs. -0.7; p=0.013) demonstrated statistically significant improvement compared to placebo on the Clinical Global Impression-Severity of Illness (CGI-S) – modified for ADHD scale, a secondary efficacy endpoint of the study.
The most common treatment-emergent adverse events (incidence =5% and =2-times placebo) leading to discontinuation for dasotraline 4 mg/day and 8 mg/day vs. placebo were insomnia (2.6% and 10.8% vs. 0.0%), anxiety (2.6% and 1.8% vs. 0.0%) and panic attacks (0.0% and 2.7% vs. 0.0%).
Sunovion recently initiated a second study that will evaluate the use of dasotraline in the treatment of adults with ADHD. The results from the first study and the recently initiated second study are intended to support a future New Drug Application 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.
Dasotraline is a new chemical entity that blocks pre-synaptic dopamine transporters (DAT) and norepinephrine transporters (NET). Dasotraline has an extended half-life that supports the potential for plasma concentrations yielding therapeutic effect over the 24-hour dosing interval at steady state.
Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is currently in development for the treatment of ADHD. Dasotraline has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD or any other disorder.