Janssen R&D announced that the Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults.
The NDA filing was based on a Phase 3, international, randomized, multicenter, double-blind, relapse prevention study of paliperidone palmitate three-month injection. The study, which included more than 500 patients, evaluated the efficacy of three-month paliperidone palmitate compared with placebo in delaying time to first occurrence of relapse symptoms of schizophrenia. Study patients who were randomized to treatment were stabilized with Invega Sustenna (once monthly paliperidone palmitate), an approved treatment for schizophrenia, prior to receiving the investigational three-month formulation. The study was stopped early since a statistically significant difference from placebo in delaying time to relapse was achieved. Based on this study, the safety profile of paliperidone palmitate three-month formulation is consistent with that of once monthly Invega Sustenna.
Invega Sustenna (paliperidone palmitate) was approved by the FDA in July 2009 as the first once-monthly atypical long-acting injection to treat. Late last year the FDA approved Invega Sustenna for the treatment of schizoaffective disorder.
For more information call (800) 526-7736 or visit InvegaSustenna.com.