The US Food and Drug Administration (FDA) has approved the atypical long-acting antipsychotic paliperidone palmitate (Invega Sustenna, Janssen Pharmaceuticals, Inc) for schizoaffective disorder, either as once-monthly monotherapy or as adjunctive treatment.
A release from the drug's manufacturer states that 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."
"Clinicians often find themselves taking a complicated approach using multiple medications to address schizoaffective disorder symptoms because widely accepted guidelines for the treatment of the condition are not available," said David P. Walling, PhD, study lead investigator and chief executive and clinical officer, Collaborative NeuroScience Network, Inc, Los Angeles.
"The approval of an effective once-monthly medication that can be used as monotherapy or adjunctive therapy to manage the symptoms associated with schizoaffective disorder has the potential to change that approach," he added.
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 showed that the drug met its primary endpoint of delayed time to, and reduced risk for, relapse compared with placebo. The company reports it also significantly improved manic and depressive mood symptoms and psychosis and that it improved and maintained patient functioning.
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Cite this: FDA Okays Antipsychotic for Schizoaffective Disorder - Medscape - Nov 14, 2014.