Patients diagnosed with schizophrenia are at risk for relapses. Janssen Pharmaceuticals, Inc. this week submitted a supplemental New Drug Application (sNDA) to FDA for its long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate), which includes new relapse data based on a head-to-head study.
“This sNDA seeks to update labeling for once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA with new investigational data showing significantly delayed time to relapse compared to selected daily oral antipsychotic therapies in the treatment of schizophrenia, which are currently the most commonly prescribed treatments,” Michelle Kramer, MD, vice president of U.S. neuroscience medical affairs for Janssen, tells Behavioral Healthcare. “Lack of consistent treatment, when and where people with schizophrenia need it, can put patients at risk for relapse, possibly leading to disability, homelessness, incarceration and other serious consequences. These new data come from Janssen’s landmark Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) study.”
PRIDE was a 15-month U.S. multicenter, prospective, randomized, open-label, blinded, active-controlled study of 444 adults with schizophrenia and a recent history of incarceration. Patients treated with paliperidone experienced a median 416 days until treatment failure vs. a median of 226 days for those treated with oral antipsychotic medications--the delay of relapse with paliperidone was 190 days longer than with oral antipsychotics. The study did not compare efficacy of paliperidone with that of individual oral antipsychotics.
INVEGA SUSTENNA was approved by the U.S. FDA in July 2009 as the first once-monthly, atypical, long-acting medication to treat schizophrenia. It is delivered by intramuscular injection. A 2010 study found the drug to have advantages over Risperdal (risperidone) long-acting injections, but with a higher cost.