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.
“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,” said Michelle Kramer, vice president, U.S. Neuroscience Medical Affairs, Janssen. “The PRIDE study shows that Invega Sustenna can play a valuable role in providing much needed consistent treatment.”
Schizophrenia is a chronic brain disorder that can be severe and disabling. The course of schizophrenia is varied for some patients, often fluctuating between a series of relapses, or return of disease after partial recovery. While there is no cure, individuals working with their treatment teams can live meaningful lives with a treatment regimen that may include medication and psychotherapy. Medication, including daily pills or long-acting monthly therapy, is the mainstay treatment for symptoms.
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. PRIDE assessed as its primary endpoint time to treatment failure, which is a subset of relapse. 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. Treatment failure was determined by an Event Monitoring Board that was blinded to treatment assignment. Invega Sustenna delayed relapse for a statistically significantly longer time period than did oral treatment. The delay of relapse with Invega Sustenna was 190 days longer than with oral antipsychotics.
“Ideally, those of us who care for patients would like to help them to be better able to work, interact in meaningful ways with family members and friends, and enjoy everyday activities that people who do not live with mental illness often take for granted,” said a trial principal investigator Mohamed Ramadan, medical director, Mohave Mental Health Clinic, Inc., Bullhead City, Arizona.
No new safety issues were observed during the study. The most commonly observed adverse events (AEs) were consistent with those listed in the current U.S. label, including injection site pain; insomnia; weight increase; akathisia, which is restlessness ranging from a feeling of inner distress to an inability to sit still; and anxiety. Among the trial participants, 53 of those taking Invega Sustenna and nine of those taking oral antipsychotics reported a treatment-emergent prolactin-related AE. Incidence of specific movement disorders associated with antipsychotics was 23.9% in the Invega Sustenna group and 18.8% in the oral antipsychotic group. A ≥7% increase in weight affected 32.4% of patients in the Invega Sustenna group and 14.4% in the oral antipsychotic group. The study AEs should be evaluated within the context of the trial design and study population.
The study was not powered to compare efficacy of Invega Sustenna with that of individual oral antipsychotics. As with any trial population, results may not be generalized to all persons with schizophrenia.
Invega Sustenna was approved by the FDA in July 2009 as the first once-monthly atypical long-acting medication to treat schizophrenia. Efficacy initially was established in four short-term studies and one longer-term study in adults.
Date: July 14, 2014