The NDA submission is based on a Phase 3, international, randomized, multicenter, double-blind, relapse prevention study of paliperidone palmitate three-month injection. The study included more than 500 patients in which the efficacy of three-month paliperidone palmitate compared to placebo in delaying time to first occurrence of relapse symptoms of schizophrenia was evaluated.
In March 2014, the Phase 3 study was stopped and unblinded, since an interim analysis demonstrated a statistically significant difference from placebo in delaying time to relapse.
Invega Sustenna (paliperidone palmitate) is already indicated as a once-monthly atypical long-acting injection for acute and maintenance treatment of schizophrenia.
For more information call (800) 526-7736 or visit InvegaSustenna.com.