FDA has approved asenapine (Saphris, Actavis) for treatment of manic or mixed episodes of bipolar I disorder in pediatric patients, ages 10 to 17 years old.
Bipolar disorder is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out daily tasks. Bipolar I disorder is defined by manic or mixed episodes, which include symptoms of both mania and depression, that last at least seven days, or manic symptoms that are so severe that the person needs immediate hospital care. Younger patients with bipolar I disorder often experience more frequent mood episodes. Approximately 1.2 million children and teens in the United States meet the criteria for bipolar I disorder.
"Bipolar I disorder in children and teens is a significant public health problem in the U.S. The diagnosis and recognition of bipolar I disorder in children and teens continues to rise, and this illness can often be more severe in pediatric patients than adults," Kiki Chang, MD, Professor of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Division of Child Psychiatry, said in a press release. "The FDA approval of this pediatric indication for Saphris is very important because it provides an additional treatment option for children and teens affected by this complex condition."
Saphris is a second-generation atypical antipsychotic which is thought to exert its therapeutic effects through dopamine and serotonin antagonism. It is the only atypical antipsychotic treatment option with a sublingual formulation and it is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last 5 years.
Saphris was initially approved in 2009 for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and for the acute and maintenance treatment of schizophrenia in adults.
The FDA approval for Saphris in the treatment of pediatric patients with bipolar I disorder is based on the results of a 3-week trial in 403 pediatric patients, aged 10 to 17 years. In the trial, Saphris demonstrated improvement in Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) Severity of Illness overall score versus placebo.
The most common side effects associated with the use of Saphris in the study include sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, tiredness, and weight gain.