Saphris becomes the first atypical antipsychotic to be approved for children with bipolar I disorder in the last five years. The medication was initially approved in 2009 for the acute treatment of bipolar I disorder and acute/maintenance treatment of schizophrenia in adults.
The FDA approval of Saphris is based on the positive results of a clinical trial of 403 children (aged 10 to 17) examining the effects of twice daily doses of 2.5 mg, 5 mg, or 10 mg of the drug.
All three dose levels were associated with improvements in both mania and overall disease severity compared with placebo. Side effects included sleepiness, dizziness, strange taste sensations, numbness of the mouth, nausea, tiredness, increased appetite, and weight gain.
Merck is responsible for product supply, and Actavis is marketing the medication. Actavis noted that Saphris will be available for pediatric patients in all three doses sometime in the second quarter of this year, and it will be available in sublingual form.
To read more about the treatment of pediatric bipolar disorder, see the FOCUS article "Management of Bipolar Disorder in Children and Adolescents."