This international, randomized, multicenter, double-blind trial (n=509) studied the efficacy of paliperidone palmitate 3-month formulation vs. placebo in delaying time to first occurrence of relapse of symptoms of schizophrenia. Patients were first stabilized with Invega Sustenna (paliperidone palmitate 1-month formulation) prior to receiving the 3-month formulation. Invega Sustenna and the paliperidone 3-month formulation incorporate proprietary NanoCrystal technology, which enables solubility of poorly water-soluble compounds.
The primary outcome was the time to first relapse event in the double-blind phase of the study. The primary analysis will be based on the interim results of the efficacy endpoint of time to first relapse. The study results will be submitted for publication in a peer-reviewed journal.
An independent data monitoring committee (IMDC) recommended to halt and unblind the clinical study based on pre-specified criteria, as the study achieved a statistically significant difference from placebo in delaying time to relapse based upon the interim analysis after 42 relapse events have occurred.
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