Sunovion submits NDA for dasotraline to US FDA to treat ADHD patients


Sunovion Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline to treat patients with attention deficit hyperactivity disorder (ADHD).

ADHD is a continuous pattern of inattention and / or hyperactivity-impulsivity that affects proper functioning and development in a person and is characterised by inattention and / or hyperactivity and impulsivity.

Sunovion’s dasotraline is a new investigational chemical entity that acts as a dual dopamine and norepinephrine reuptake inhibitor (DNRI) and can be used for the treatment of children, adolescents and adults with ADHD.

Sunovion executive vice-president and chief medical officer Dr Antony Loebel said: “This milestone embodies Sunovion’s commitment to advancing psychiatry and neurology through the development of novel treatment options to improve the lives of those living with behavioural health conditions.

“People with ADHD suffer from inattention, as well as hyperactive-impulsive behaviours that may interfere with school, work and social functioning.

"Dasotraline is a once-daily medication that may add to current treatment options by providing sustained symptom improvement without wearing off between doses."

“Dasotraline is a once-daily medication that may add to current treatment options by providing sustained symptom improvement without wearing off between doses. In addition, studies indicate that dasotraline is associated with a relatively low potential for abuse.”

The NDA submission for dasotraline is based on the data derived from the clinical programme for dasotraline in ADHD.

The programme included four placebo-controlled safety and efficacy studies and two long-term studies conducted to evaluate the safety of dasotraline in patients with ADHD for up to one year.

The studies involved a total of 2,500 patients with ADHD who were investigated after being administered with dasotraline dosages in the range of 2mg to 8mg per day.

The therapy is currently being investigated for the potential treatment of binge eating disorder (BED) in adults.