Janssen Pharmaceuticals, Inc., announced INVEGA SUSTENNA (paliperidone palmitate), a once-monthly schizophrenia treatment, is the first and only antipsychotic to have the U.S. Food and Drug Administration (FDA) approve the inclusion of real-world data in its product labeling. These data come from the Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) study and demonstrate:
- The superior effectiveness of INVEGA SUSTENNA® versus a group of seven commonly prescribed oral antipsychotics in delaying time to relapse, and
- The time to first psychiatric hospitalization or arrest and/or incarceration was significantly longer for people treated with INVEGA SUSTENNA versus these same commonly prescribed oral antipsychotics.
“This important study helped us better understand the effectiveness of antipsychotic treatments when used outside the controlled setting of a typical clinical trial, where difficult circumstances like hospitalization, incarceration and substance abuse are an unfortunate reality for individuals living with schizophrenia,” explained trial investigator Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center. “Healthcare providers often treat schizophrenia with oral medications and do not offer the option of long-acting therapy until later in the treatment journey, when the disease has advanced. Based on the addition of this comparative evidence to the Invega Sustenna label, healthcare professionals should consider the benefits of earlier treatment with a long-acting therapy in their adult patients living with schizophrenia.”
This study has the potential to address key issues impacting the broader healthcare system. Today, the criminal justice system is the largest provider of mental health care in the United States, in part due to variable access to care. People in this country living with serious mental illness (SMI), including those with schizophrenia, are three times more likely to be in jail or prison than a hospital, often as a result of their symptoms. Despite widespread use of antipsychotics, sometimes people have difficultly taking daily medication as prescribed, increasing the risk of their symptoms returning. These repeated cycles of relapse lead to costly events, such as hospitalization or incarceration.
“When a treatment fails and a person living with schizophrenia relapses, it’s not only extraordinarily discouraging and difficult for the individual and their family, it can also be burdensome and costly for our healthcare system,” said Michelle Kramer, MD, MPH, Vice President, Neuroscience Medical Affairs, Janssen. “The inclusion of this novel evidence in the Invega Sustenna label will help adults living with schizophrenia and their healthcare providers see what’s possible with the right treatment plan and support.”
The label update is based on data from the groundbreaking PRIDE study and reflects the clinical and real-world benefits of INVEGA SUSTENNA®(paliperidone palmitate). The comparative efficacy PRIDE trial was a 15-month, multi-center, prospective, randomized, open-label, active-controlled study of 444 adults with schizophrenia. Participants were enrolled at 50 sites across the United States and Puerto Rico.
The trial was uniquely designed to mirror the population of adults living with schizophrenia that healthcare professionals commonly see in clinical practice. All trial participants were adults who had been diagnosed with schizophrenia and taken into custody by the criminal justice system at least twice in the previous two years, with at least one custody resulting in incarceration. This trial allowed participation by those often excluded from trials, such as individuals with a recent history of incarceration, as well as those who had self-reported substance or alcohol abuse just prior to trial enrollment or who had a current diagnosis of a substance abuse disorder. Patients who had abused intravenous drugs within three months of screening or had an opiate dependence disorder were not included in the trial.
The PRIDE study was originally published online in The Journal of Clinical Psychiatry on April 14, 2015.
In the PRIDE study, participants were randomized to either monthly INVEGA SUSTENNA or one of seven commonly prescribed daily antipsychotic therapies used in the United States: aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine and risperidone. Clinicians were permitted to determine the appropriate oral antipsychotic based on a patient’s prior experience, as is typical in the real world. The study was not powered to compare the efficacy of INVEGA SUSTENNA with that of the individual commonly prescribed oral antipsychotics used in the study.
The primary study endpoint was median length of time to the first treatment failure or relapse. The results found that INVEGA SUSTENNA delivered a statistically significant delay in relapse, more than six months longer than a group of seven commonly prescribed oral antipsychotics (median 416 days versus median 226 days; P=0.011). The time to first psychiatric hospitalization or arrest and/or incarceration was also significantly longer for the INVEGA SUSTENNA group versus the oral antipsychotic group.
In this study, treatment failure was defined as psychiatric hospitalization; arrest/incarceration; suicide; treatment supplementation/discontinuation of antipsychotic treatment because of inadequate efficacy, safety, or tolerability; or need for increased psychiatric services to prevent imminent psychiatric hospitalization.
No new safety issues were observed during the study.
INVEGA SUSTENNA adverse reactions during placebo-controlled studies (≥5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder. During the PRIDE study, the most common adverse reactions (≥5% and twice oral antipsychotic group) were injection site pain, weight increased, fatigue, erectile dysfunction and libido decreased.
Filed Under: Drug Discovery