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# Janssen sNDA for 6-month Schizophrenia Dosing
- URL: https://www.fdaweb.com/janssen-snda-for-6-month-schizophrenia-dosing/
- Published: 2020-11-02T12:00:00.000Z
- Updated: 2026-09-14T16:34:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148000

Janssen Pharmaceutical has submitted a supplemental NDA for paliperidone palmitate 6-month (PP6M) for treating adults diagnosed with schizophrenia. If approved, PP6M will be the first and only long-acting injectable schizophrenia medication with a twice-yearly dosing regimen, Janssen says. FDA approved a Janssen NDA in 2015 for Invega Trinza (paliperidone palmitate), a three-month long-acting atypical antipsychotic indicated to treat schizophrenia.

The submission is based on data from the Route 6 Study, a randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults living with schizophrenia from 20 countries. “Data showed non-inferior efficacy of PP6M compared to paliperidone palmitate 3-month (PP3M) on the primary endpoint of time to relapse at the end of the 12-month period in both intent-to-treat and per-protocol analysis sets,” the company says. And its safety profile was consistent with previous studies of paliperidone palmitate, it says.