TITUSVILLE, NJ, July 14, 2014 – Janssen Pharmaceuticals, Inc. today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a label change that, if approved, would include new data showing significantly delayed time to relapse in patients prescribed once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) compared to selected oral antipsychotic therapies in the treatment of schizophrenia. The sNDA is supported by the landmark Paliperidone Palmitate Research In Demonstrating Effectiveness study (PRIDE), which is the first prospective, randomized clinical trial to evaluate schizophrenia treatments within the context of many “real world” issues faced by patients in their daily lives, including one of the most challenging circumstances – recent incarceration.
Janssen Pharmaceuticals Seeks Expanded Label for Once-Monthly INVEGA® SUSTENNA® (paliperidone palmitate) to Show Delayed Time to Relapse Compared to Daily Oral Schizophrenia Therapies | Johnson & Johnson
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