FDA Adds Study Data to Schizophrenia Drug Labeling

Deborah Brauser

January 04, 2018

The US Food and Drug Administration (FDA) has approved the inclusion of phase 3 study data in product labeling for the once-monthly schizophrenia treatment paliperidone palmitate (Invega Sustenna, Janssen), according to an announcement from the manufacturer.

The randomized Palpiderone Palmitate Research In Demonstrating Effectiveness (PRIDE) trial comprised patients not usually included in clinical research. All 444 adult patients had schizophrenia and had been taken into custody and jailed at least once in the previous 2 years.

Results showed that for those who received the study drug, time to relapse was significantly delayed, as was time to psychiatric hospitalization or repeated arrest and/or incarceration, compared with a group of participants who received one of seven commonly prescribed oral antipsychotics.

"This important study helped us better understand the effectiveness of antipsychotic treatments when used outside the controlled settings of a typical clinical trial, where difficult circumstances...are an unfortunate reality for individuals living with schizophrenia," PRIDE investigator Martha Sajatovic, MD, University Hospitals Cleveland Medical Center, Ohio, said in the release.

The treatment "is the first and only antipsychotic to have the [FDA] approve the inclusion of real-world data in its product labeling," reports the pharmaceutical company.

"Breaking the Cycle"

The drug received approval from the FDA for treating schizophrenia in 2009. The drug has received similar approval from more than 80 other countries. In 2014, the FDA also approved it for treating schizoaffective disorder, but patients with this condition were not included in the PRIDE trial.

PRIDE, which was published in 2015 in the Journal of Clinical Psychiatry, included 444 adults with schizophrenia. Patients were enrolled at 50 sites in the United States and Puerto Rico. In addition to having a recent history with the criminal justice system, many participants reported substance or alcohol abuse or had a current diagnosis of a substance abuse disorder.

Trial exclusions included intravenous drug use during the 3 months prior to screening or having an opiate dependence disorder.

The participants were randomly assigned to monthly treatment with paliperidone palmitate or one of the following: paliperidone, perphenazine, risperidone, haloperidol, aripiprazole, olanzapine, and quetiapine.

The median time to relapse was 416 days for the study-drug group vs 226 days for the combined comparator/control group (P = .011). The most common treatment-related adverse events in the trial included injection site pain, weight gain, fatigue, erectile dysfunction, and decreased libido.

Overall, the data "brought hope in breaking the cycle of hospitalization and incarceration," the manufacturer noted in the release.

On the basis of comparative results, which will now be added to the drug's label, "healthcare professionals should consider the benefits of earlier treatment with a long-acting therapy in [those] living with schizophrenia," said Dr Sajatovic.

The study data will be added to the label under the subhead, Long-Term Comparative Monotherapy Treatment Versus Oral Antipsychotic Therapy (Study 6: SCH-3006).

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