ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating schizophrenia and bipolar I disorder, the agency announced Friday.
The FDA approved Schering-Plough Corp.’s Saphris (asenapine), a tablet for treating the two illnesses in adults.
“Mental illnesses like schizophrenia and biopolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” FDA Center for Drug Evaluation and Research Division of Psychology Products director Thomas Laughren said in a statement. “Effective medicines can help people with mental illnesses live more independent lives.”
Because it belongs to the class known as atypical antipsychotics, Saphris carries a boxed warning, the FDA’s strongest warning label. The warning alerts prescribers to the risk of death when the drug is used to treat behavioral problems in elderly people with dementia-related psychosis. The drug is not approved for treating that condition.