FDA issues complete response letter regarding ADHD drug application
The US Food and Drug Administration (FDA) responded to Sunovion Pharmaceuticals’ new drug application (NDA) for dasotraline, an ADHD treatment, with a complete response letter stating that additional clinical data was needed to evaluate the efficacy and tolerability of the drug.
ADHD, or attention deficit hyperactivity disorder, interferes with functioning and development and can be debilitating for an individual.
Dasotraline is a dual dopamine and norepinephrine reuptake inhibitor (DNRI). The candidate was evaluated in roughly 2,500 children and adults with ADHD in multiple placebo-controlled safety and efficacy studies. Sunovion also conducted two long-term safety studies.
It is also, currently, being studied for the treatment of severe binge eating disorder (BED) in adults. Based on the current data of the BED studies the company expects to release a marketing application to the FDA to treat BED within the 2018 financial year.
There are multiple DNRI medications available for the treatment of ADHD, such as, Ritalin, Wellbutrin, and Meratran. The reuptake of norepinephrine and dopamine increase cortical arousal, which helps individuals with ADHD concentrate – a primary issue in the condition.