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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.