FDA to Review Novel ADHD Treatment Dasotraline

Two year-long studies assessing safety of dasotraline in children, adolescent and adult ADHD patients found the treatment to be generally well tolerated.

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. 

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

For more information visit Sunovion.us.