Sunovion submits new drug application for novel ADHD dication
Sunovion Pharmaceuticals last month announced that the FDA has accepted for review a New Drug Application (NDA) for dasotraline-a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of ADHD in children and adults
This drug has an extended half-life (47 to 77 hours) that supports the potential for achieving a continuous therapeutic effect with once-daily dosing.
According to Sunovion, the NDA includes data from multiple placebo-controlled safety and efficacy studies as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year. These studies, which included about 2,500 people with ADHD, suggest the medication is generally well tolerated, the company said.