Three-month paliperidone palmitate, an investigational atypical antipsychotic developed by Janssen Research & Development, LLC, significantly delayed relapse time compared with a placebo in patients with schizophrenia, according to a new Phase 3 clinical study recently 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, the study sponsor. The FDA granted the filing Priority Review status in January, with a regulatory action date of May 18, 2015.
This Phase 3, international, randomized, multicenter, double-blind, placebo-controlled, relapse prevention study evaluated 305 adults in the double-blind phase. There were 160 study patients in the three-month paliperidone palmitate treatment group and 145 patients in the placebo group. All of the patients enrolled in the study met the DSM-IV diagnosis of schizophrenia and had a Positive and Negative Syndrome Scale (PANSS) total score of fewer than 120 at screening and baseline.
If approved, the treatment would enable patients to receive injections once every three months, compared to the typical monthly dosage, 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 anticipates filings for three-month paliperidone palmitate in many markets outside of the U.S. later this year.
“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 for 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.”