FDA approves Invega Sustenna for Schizoaffective Disorder-Janssen Pharma

The FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate), from Janssen Pharmaceuticals, to treat Schizoaffective Disorder as either monotherapy or adjunctive therapy. The FDA approved these sNDAs under priority review.

The approval is based on data from a 15-month period of a long-term maintenance study measuring ability to delay relapse in schizoaffective disorder. The study found that treatment with Invega Sustenna resulted in a statistically significant delay in relapse due to mood (depression and mania) and psychotic symptoms of schizoaffective disorder compared to placebo. Results of the study were presented in May at the 167th Annual Meeting of the American Psychiatric Association.