Janssen R&D announced that results from a Phase 3 clinical study with three-month paliperidone palmitate have been published in JAMA Psychiatry.

This international, randomized, multicenter, double-blind, placebo-controlled, relapse prevention study randomized patients to either the three-month paliperidone palmitate treatment group (n=160) or to the placebo group (n=145). All enrolled patients met the DSM-IV diagnosis of schizophrenia and had a Positive and Negative Syndrome Scale (PANSS) total score of <120 at screening and baseline. Prior to randomization, individuals were first stabilized with Invega Sustenna (paliperidone palmitate) one-month formulation during a 17-week, open-label transition period. Patients who met criteria for clinical stability then received a single three-month paliperidone palmitate injection during a 12-week, open-label maintenance phase. Stable patients were then randomized to treatment with either three-month paliperidone palmitate or placebo. Patients remained in the double-blind phase (n=305) until they relapsed, withdrew from the study, or the study terminated.

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After the first 42 relapse events occurred in the double-blind phase, a pre-specified interim analysis showed that three-month paliperidone palmitate significantly delayed time to relapse compared to placebo (HR 3.45; 95% CI: 1.73–6.88; p=0.0002; median time to relapse for placebo group: 274 days). Final analysis results were consistent with that of the interim analysis, confirming three-month paliperidone palmitate’s superiority over placebo for delaying time to relapse of schizophrenia symptoms (HR 3.81; 95% CI: 2.08–6.99; p<0.0001; median time to relapse for placebo group: 395 days, and three-month paliperidone palmitate group: not estimable).

The results of this study were previously submitted to the Food and Drug Administration (FDA) to support the New Drug Application (NDA) filing for three-month paliperidone palmitate injection to treat schizophrenia in adults.

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