Invega Sustenna (paliperidone palmitate; Janssen) for injection was effective six months longer than common oral antipsychotics in patients with schizophrenia, according to results from the PRIDE study. The full results are published in The Journal of Clinical Psychiatry.
The PRIDE (Paliperidone Palmitate Research In Demonstrating Effectiveness) study was a 15-month, prospective, randomized, open-label, active-controlled study (n=444) that evaluated schizophrenia treatments in the setting of real-world management of the condition. Real-world is defined by the patients included in the trial, the flexibility of medication options, and measurement of common outcomes seen in this population (eg, incarceration, hospitalization).
Patients across 50 sites were randomized to either monthly Invega Sustenna (78–234mg) or one of seven flexibly-dosed, common daily oral antipsychotic: aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone. The primary study endpoint was the length of time to the first treatment failure or relapse. Study findings showed that Invega Sustenna delayed relapse significantly longer than oral treatment (median 416 vs. 226 days; P=0.011).
The Food and Drug Administration (FDA) is reviewing a supplemental New Drug Application (sNDA) to include trial data into the Invega Sustenna label.
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