Janssen files NDA at FDA for three months formulation of Invega Sustenna for Schizophrenia

Janssen Research & Development, LLC (Janssen) has announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic Invega Sustenna (paliperidone palmitate) to the FDA. The NDA seeks approval for the medication as a treatment for Schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.

The filing was based on a Phase III, 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.

In March 2014, Janssen announced that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it halted the Phase III clinical study of paliperidone palmitate three-month formulation early. The recommendation to stop and unblind the clinical study at the interim analysis was made by the IDMC based on pre-specified criteria, specifically achieving a statistically significant difference from placebo in delaying time to relapse. Based on this study, the safety profile of paliperidone palmitate three-month formulation is consistent with that of once-monthly Invega Sustenna