New study finds three-month paliperidone palmitate significantly delayed time to relapse in patients with schizophrenia

Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to a new Phase 3 clinical study published in the Journal of the American Medical Association (JAMA) Psychiatry. 

Results of the study served as the basis for the recent New Drug Application (NDA) filing for three-month paliperidone palmitate injection to treat schizophrenia in adults with the U.S. Food and Drug Administration (FDA) by Janssen Research & Development, the study sponsor. The FDA granted the filing Priority Review status in January, with a regulatory action date of May 18, 2015.

Janssen plans filings for three-month paliperidone palmitate in markets outside of the U.S.

If approved, the treatment would enable patients to receive injections once every three months, compared to currently available formulations that are administered monthly, or oral medicines that must be taken daily. It would be the first and only long-acting atypical antipsychotic with a dosing schedule of four times a year. Janssen plans filings for three-month paliperidone palmitate in many markets outside of the U.S. later this year.

The final published analysis results are consistent with previously announced interim analysis results which showed a statistically significant benefit of three-month paliperidone palmitate compared to placebo. In March 2014, following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, Janssen halted this study early.

The study data are also being presented at the 23rd annual European Congress of Psychiatry in Vienna, Austria, and at the 15th annual International Congress on Schizophrenia Research in Colorado Springs, Colorado.

“There remains significant unmet need for the approximately 2.4 million people in the United States who live with schizophrenia. The results of this study reinforce the need for this unprecedented treatment option for patients with schizophrenia who may benefit from a new, less frequently dosed treatment choice,” said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen. “We look forward to continuing to work with the FDA and other regulatory authorities to bring this innovative three-month formulation to patients as soon as possible.”

“Physicians need a broad range of treatments to help patients with schizophrenia early in the course of their disease,” said David Hough, MD, Schizophrenia Disease Area Leader, Janssen, a study author. “This clinical trial showed three-month paliperidone palmitate demonstrated a statistically significant difference from placebo in delaying time to relapse, validating its potential as a new treatment option which could positively affect the care of people with schizophrenia.”

For more information on Janssen Pharmaceuticals, Inc., please visit www.JanssenPharmaceuticalsInc.com.