Sunovion Pharmaceuticals Inc. said last week its novel drug candidate dasotraline was successful in treating children with ADHD, showing statistically significant improvements.
The Marlborough drugmaker said children ages six to 12 with attention-deficit/hyperactivity disorder who were given four milligrams of dasotraline a day experienced statistically significant improvements for up to 24 hours after taking the drug, compared to placebo. Although dasotraline was generally well-tolerated in the phase 3 study, about 5 percent of patients reported feeling side effects, such as insomnia, decrease appetite, headache, irritability and rapid change in emotion.
Sunovion said it plans to submit a new drug application for the treatment of ADHD to the U.S. Food and Drug Administration in fiscal year 2017.
The company is also investigating dasotraline’s potential to treat binge eating disorder in adults in the U.S.
