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Study Shows Injectable Paliperidone (Invega Sustenna) Effective 6 Months Longer Than Oral Antipsychotics in Patients With Schizophrenia

First trial to evaluate schizophrenia treatments in ‘real world’ settings

A study published in the Journal of Clinical Psychiatry has shown that long-acting injectable paliperidone palmitate (Invega Sustenna, Janssen) was effective 6 months longer than commonly prescribed oral antipsychotics in patients with schizophrenia, delaying relapse.

Conducted over a 15-month period, the PRIDE (Paliperidone Palmitate Research In Demonstrating Effectiveness) study was the first prospective, randomized clinical trial to evaluate schizophrenia treatments within the context of “real world” issues faced by patients in their daily lives, including challenging situations such as recent incarceration or substance abuse.

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.

The PRIDE trial was an open-label, active-controlled study of 444 adults with schizophrenia that was designed to reflect “real world” management of schizophrenia. The term “real world” was defined by the patients included in the trial, by the broad flexibility in medication options, and by the measurement of common outcomes in this population, such as incarceration and hospitalization.

The participants were enrolled in 25 states in the U.S. and in Puerto Rico. To enhance enrollment of individuals who are often excluded from studies, 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 who had a current diagnosis of a substance abuse disorder.

The participants were randomly assigned to receive either monthly injections of paliperidone palmitate (78 mg to 234 mg) or one of seven flexibly dosed, daily oral antipsychotic medications commonly prescribed in the U.S., including aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone. The study was not powered to compare the effectiveness of paliperidone palmitate with that of individual oral antipsychotics.

Paliperidone palmitate delayed relapse for a significantly longer period compared with oral treatment (median: 416 days vs. 226 days, respectively; P = 0.011).

The study’s primary endpoint was the length of time to the first treatment failure or relapse. In this study, treatment failure was defined as psychiatric hospitalization; arrest and incarceration; suicide; treatment supplementation or discontinuation of the antipsychotic medication because of 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% vs. 29.4% and 8.0% vs. 11.9%, respectively).

During the trial, commonly reported treatment-emergent adverse events in the paliperidone palmitate group included injection-site pain, insomnia, weight increase, akathisia, and anxiety.

Schizophrenia 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.

Invega Sustenna (paliperidone palmitate) was approved by the FDA in July 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia. In late 2014, the FDA approved Invega Sustenna for the treatment of schizoaffective disorder, making it the only once-monthly medication to treat this condition; however, this population was not studied as part of the PRIDE trial.

Source: PR Newswire; April 15, 2015.

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