Sunovion has submitted a New Drug Application (NDA) for dasotraline, a novel investigational treatment for attention deficit hyperactivity disorder (ADHD).

Dasotraline is a new chemical entity that acts as a dual dopamine and norepinephrine reuptake inhibitor (DNRI). The NDA submission is based on data from a clinical program that included four 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 extended half-life of 47–77 hours supports the potential for stable plasma concentrations yielding a continuous therapeutic effect over 24-hours. 

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“Dasotraline is a once-daily medication that may add to current treatment options by providing sustained symptom improvement without wearing off between doses,” said Antony Loebel, MD, EVP and CMO at Sunovion. 

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Sunovion is also investigating dasotraline for the treatment of binge eating disorder (BED) in adults. 

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