Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study.
The improvement was observed in the 4mg/day dose arm, while the 2mg/day dose arm did not show a statistically significant difference from placebo.
Both dasotraline arms were generally well tolerated with an adverse event (AE) profile consistent with completed adult dasotraline trials.
Insomnia, decreased appetite and weight decreased were the most common treatment-emergent adverse events that were reported in 5% or more of patients and greater than placebo.
Dasotraline is a new chemical entity that is considered to be a dopamine and norepinephrine reuptake inhibitor.
Sunovion said the drug has an extended half-life that supports the potential for plasma concentrations generating a continuous therapeutic effect over the 24-hour dosing interval at steady state.
Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is currently in development to evaluate its use in treating ADHD in adults and children and binge eating disorder (BED) in adults in the US.
After completion of ongoing studies and negotiations with the FDA, Sunovion plans to submit a new drug application in the US in 2017 for ADHD in children and adults.
Sunovion Pharmaceuticals executive vice president and chief medical officer Antony Loebel said: “Sunovion is dedicated to advancing the treatment of serious neuropsychiatric conditions, such as ADHD.
“These study results are encouraging and support the efficacy and safety of dasotraline for the treatment of ADHD.”
Image: Sunovion Pharmaceuticals executive vice president and chief medical officer Antony Loebel. Photo: courtesy of Sunovion Pharmaceuticals Inc.