Sunovion announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for dasotraline, an investigational treatment for attention-deficit hyperactivity disorder (ADHD).
Dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), was studied in approximately 2500 children and adults with ADHD. The drug has an extended half-life with 47-77 hours in adults and 58-84 hours in children; this allows for stable plasma concentrations and a sustained clinical effect over 24 hours.
The NDA for dasotraline, submitted in August 2017, included data from a clinical program that included 4 placebo-controlled safety and efficacy studies, as well as two long-term studies assessing the safety of dasotraline in patients with ADHD for up to one year. The FDA stated that the dasotraline NDA cannot be approved in its current form and is requiring additional data to further assess the efficacy and tolerability of the drug. Sunovion EVP, CEO, Antony Loebel, MD, said, “We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible.”
Dasotraline is also being evaluated as a treatment of moderate to severe binge eating disorder (BED) in adults. Findings from 2 pivotal studies will be included in the application submission to the FDA in fiscal year 2018.
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