Janssen Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under priority review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.
INVEGA SUSTENNA is the first and only FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy.
“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.”
