In March this year, the company secured approval from the US Food and Drug Administration (FDA) for Saphris for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients aged ten to 17 years.
The FDA approval of Saphris was based on data from a three-week monotherapy trial in 403 pediatric patients.
Allergan Global R&D executive vice-president David Nicholson said: "The approval of the pediatric indication and the availability of Saphris 2.5mg tablets at pharmacies throughout the US means that children, teens and their physicians will have a new treatment option available for this complex disorder."
In the US, around half a million children and teens have experienced symptoms of bipolar I disorder at some time in their lives.
Patients with bipolar I disorder experience ‘mood episodes’, which include manic episodes or mixed episodes.
Children’s National Medical Center Division of Psychology and Behavioral Health chief Adelaide Robb said: "Children with bipolar I disorder can present with varying symptoms and needs, which requires that physicians address the critical need for individualized treatment.
"Saphris provides an important option for pediatric patients living with this debilitating and serious psychiatric mood disorder."