FDA Approves Drug for Schizoaffective Disorder
The FDA approved paliperidone palmitate, an atypical long-active antipsychotic, manufactured by Janssen Pharmaceuticals, Inc, for the treatment of schizoaffective disorder. The drug is taken either as a once-monthly injection monotherapy or as an adjunctive treatment.
The FDA approved the new indication for the drug "under priority review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions,” according to the manufacturer.
According to the company, the FDA approval of the new indication was based on data from a 6-month, open-label treatment period and a 15-month, double-blind period. The results demonstrated that the drug met its primary end point of delayed time to, and reduced risk for, relapse compared with placebo. The company reported that it also significantly improved manic and depressive mood symptoms and psychosis and that it improved and maintained patient functioning.
The drug was previously indicated for schizophrenia. The drug is not approved for use in patients with dementia-related psychosis.—Kerri Fitzgerald
