sNDA Submitted for Invega Sustenna Label Expansion
Janssen announced submission of a supplemental New Drug Application (sNDA) to the FDA for a label change to include new data demonstrating significantly delayed time to relapse in patients taking Invega Sustenna (paliperidone palmitate) compared to other selected oral antipsychotics for the treatment of schizophrenia.
The sNDA is supported by the Paliperidone Palmitate Research In Demonstrating Effectiveness study (PRIDE), a 15-month multicenter, prospective, randomized, open-label, blinded, active-controlled study of 444 adults with schizophrenia and a recent history of incarceration. The primary endpoint was time to treatment failure. In this study, this endpoint was defined as any one of the following: psychiatric hospitalization; arrest/incarceration; suicide; treatment supplementation or discontinuation of antipsychotic medication because of inadequate efficacy, safety concerns or tolerability issues; or increased level of psychiatric services to prevent psychiatric hospitalization.
Invega Sustenna delayed relapse for a statistically significantly longer time period than did oral treatment (median 416 days vs. median 226 days; P=0.011). The delay of relapse with Invega Sustenna was 190 days longer than with oral antipsychotics.
Invega Sustenna is an atypical antipsychotic already approved for the treatment of schizophrenia.
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