Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval for a six-month long-acting injectable (LAI) version of the antipsychotic paliperidone palmitate six-month (PP6M) as a treatment for schizophrenia. Janssen submitted a supplemental new drug application to the U.S. Food and Drug Administration (FDA), and intends submit a Marketing Authorization Application extension to the European Medicines Agency (EMA) for PP6M in the coming months. If approved, PP6M will be the first and only LAI schizophrenia treatment with a twice-yearly dosing regimen.

The FDA submission is based on the Route 6 Study, a randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults living with schizophrenia from 20 countries. PP6M was as effective as paliperidone palmitate 3-month (PP3M) on the primary endpoint of time to relapse at the end of the 12-month period The safety profile observed for PP6M was consistent with previous studies of paliperidone palmitate 1-month (PP1M) and 3-month (PP3M) formulations with no new safety signals emerging.

PP6M is intended to be used only after patients have been stabilized on a shorter acting formulation of paliperidone palmitate (PP1M or PP3M), with the goal of administering fewer injections. The Janssen U.S. portfolio of LAI medicines currently approved to treat adults with schizophrenia includes RISPERDAL CONSTA 2 (risperidone 2-weekly), INVEGA SUSTENNA 3 and INVEGA TRINZA 4 (PP1M and PP3M formulations, respectively), all of which are administered in a clinical setting by a medical professional.

This was reported by Janssen Pharmaceutical Companies of Johnson & Johnson on November 2, 2020.

Contact information: Stela Meirelles, Senior Director, Global Communications & Public Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, 1000 U.S. Route 202 South, Raritan, New Jersey 08869; 732-258-1540; Website: www.janssen.com