A study published in The Journal of Clinical Psychiatry shows that long-acting INVEGA SUSTENNA® (paliperidone palmitate) was effective six months longer than commonly prescribed oral antipsychotics in patients with schizophrenia, delaying relapse such as hospitalization, arrest and incarceration. Conducted over a 15-month period, the Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) study is the first prospective, randomized clinical trial to study schizophrenia treatments within the context of many real-world issues faced by patients in their daily lives, including challenging situations such as recent incarceration or substance abuse.
"Janssen designed and executed this innovative trial to account for the real-world context in which those living with schizophrenia and their families seek treatment options," said trial co-author Larry Alphs, MD, PhD, Psychiatry Therapeutic Team Lead, Medical Affairs, Janssen Pharmaceuticals, Inc. "This clinical trial showed that INVEGA SUSTENNA® effectively treats patients with schizophrenia six months longer than oral antipsychotics, which is incredibly meaningful for patients, their caregivers and providers as they explore treatment options."
The FDA is currently reviewing a supplemental New Drug Application (sNDA) to update the INVEGA SUSTENNA® label to include data from this trial. The sNDA was filed in July 2014, and the action date for this application is May 11, 2015.
"Across the U.S., seriously mentally ill persons, including persons with schizophrenia, are three times more likely to be in jail or prison versus being in a hospital, creating a large and costly problem for the U.S. healthcare system," said trial investigator Jason Bermak, MD, PhD, Medical Director of SF-CARE, Inc. "This study addresses the fact that the lack of consistent treatment can put patients at risk for relapse, possibly leading to incarceration, hospitalization and other serious consequences. However, with proper treatment and support, individuals living with schizophrenia can and do live meaningful lives."
Trial Design
The trial was a 15-month multicenter, prospective, randomized, open-label, active-controlled study of 444 adults with schizophrenia that was designed to reflect real-world management of schizophrenia. Real world is defined by the patients included in the trial, the broad flexibility in medication options, and measurement of common outcomes in this population, such as incarceration and hospitalization.
Participants were enrolled at 50 sites across 25 U.S. states and Puerto Rico. To enhance enrollment of individuals who are often excluded from trials, efforts were made to recruit participants from nontraditional locations, such as homeless shelters, soup kitchens, and jail-release or diversion programs. Therefore, trial participants included those with a recent history of incarceration, who had self-reported substance or alcohol abuse just prior to trial enrollment, or had a current diagnosis of a substance abuse disorder. This patient population is more reflective of real-world clinical practice than that which is typically recruited for clinical trials.
Participants were randomized to either monthly INVEGA SUSTENNA® (78-234 mg) or one of seven flexibly-dosed, common daily oral antipsychotic medications prescribed in the U.S., including aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine and risperidone. The study was not powered to compare effectiveness of INVEGA SUSTENNA® with that of individual oral antipsychotics.
Trial Results
Study results indicate that INVEGA SUSTENNA® delayed relapse for a significantly longer time period than did oral treatment (median 416 days vs. median 226 days; P = 0.011).
The primary study endpoint was the length of time to the first treatment failure or relapse. In this study, treatment failure was defined as psychiatric hospitalization; arrest/incarceration; suicide; treatment supplementation or discontinuation of antipsychotic medication due to inadequate efficacy, safety concerns or tolerability issues; or increased psychiatric services to prevent psychiatric hospitalization. Arrest/incarceration and psychiatric hospitalization were the most common reasons for treatment failure in the paliperidone palmitate and oral antipsychotic groups (21.2 percent vs. 29.4 percent and 8.0 percent vs. 11.9 percent, respectively).
No new safety issues were observed during the study. During the trial, commonly reported treatment-emergent adverse events (≥10% of INVEGA SUSTENNA® patients) included injection site pain; insomnia; weight increase; akathisia, which is a feeling of inner restlessness or needing to be constantly moving; and anxiety.
About Schizophrenia
Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It affects approximately 2.4 million U.S. adults, often beginning in the late teens or early 20s. The disease typically manifests as hallucinations, delusions, and disorganized thoughts and behavior.
Because there are currently no physical or laboratory tests that diagnose this condition, schizophrenia is diagnosed by the presence of symptoms. Researchers have identified various risk factors for this disease, including heredity and certain genetic risk factors, and environmental factors, such as social stress, isolation and drug use. If left untreated, schizophrenia can greatly interfere with education, employment and interpersonal functioning. The course of schizophrenia is varied, generally involving a series of relapses or the return of symptoms after partial recovery.
About INVEGA SUSTENNA®
INVEGA SUSTENNA® (paliperidone palmitate) was approved by the U.S. FDA in July 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries. Late last year the FDA approved INVEGA SUSTENNA® for the treatment of schizoaffective disorder, making it the first and only once-monthly medication to treat this condition; however, this population was not studied as part of the PRIDE trial.