For the first time in 5 years, the Food and Drug Administration has approved an application to market an antipsychotic to clinicians for treating bipolar I disorder in children aged 10-17 years.
Actavis, the Dublin-based pharmaceutical manufacturer, announced March 13 that the FDA has approved the company’s supplemental new drug application for asenapine (Saphris), a second-generation atypical antipsychotic, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in this pediatric population.
The FDA approved asenapine in 2009 for treating adults with manic or mixed episodes of bipolar I, either as monotherapy or adjunctive to either lithium or valproate. It also is indicated for the acute or maintenance treatment of schizophrenia in adults.
Asenapine is administered as a sublingual tablet, and the company announced in the statement that it would begin marketing black cherry–flavored sublingual asenapine tablets in 2.5 mg, 5 mg, and 10 mg doses beginning in the second quarter of this year.
According to the manufacturer, the agency’s approval was granted based on the results of a 3-week monotherapy trial in 403 pediatric patients, aged 10-17 years, 302 of whom were treated twice daily with either 2.5 mg, 5 mg, or 10 mg of asenapine. The drug maker also said asenapine demonstrated improvement in the Young Mania Rating Scale total score and the Clinical Global Impressions-Bipolar Scale overall score, compared with placebo.
When asked about the approval, Dr. David Fassler said it's helpful to have a range of medications to treat pediatric patients with bipolar disorder. "However, the current approval is based on results of a relatively short-term clinical trial," said Dr. Fassler, clinical professor of psychiatry at the University of Vermont, Burlington. "In the real world, many young people ultimately take atypical antipsychotics for an extended period of time. Physicians and parents need data on the safety and efficacy of these medications when used on a more long-term or ongoing basis in order to make fully informed decisions about treatment options."
The most common side effects the company said it recorded in the pediatric clinical trial were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.
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