Johnson & Johnson's (JNJ +0.2%) Janssen Pharmaceuticals submits an sNDA for an expanded indication for Invega Sustenna (paliperidone palmitate). The label change, if approved, would include data showing significantly delayed time to relapse in patients treated with Invega Sustenna compared to selected oral antipsychotic therapies in the treatment of schizophrenia.
In a 444-patient clinical trial, whose time to treatment failure was the primary endpoint, Invega Sustenna patients' delay of relapse was 190 days longer compared to other oral antipsychotics. The results were statistically significant.
The FDA first approved the product in July 2009 as a treatment for schizophrenia.