FDA Grants Priority Review to Schizophrenia Treatment

January 19, 2015
Ryan Marotta, Assistant Editor

Janssen announced today that the FDA has granted Priority Review designation to its New Drug Application (NDA) for paliperidone palmitate, a 3-month atypical antipsychotic for treating schizophrenia in adults.

Janssen announced today that the FDA has granted Priority Review designation to its New Drug Application (NDA) for paliperidone palmitate, a 3-month atypical antipsychotic for treating schizophrenia in adults.

The NDA for paliperidone palmitate 3-month injection was filed following a phase 3, international, randomized, multicenter, double-blind, relapse prevention study on the drug. The trial, which enrolled more than 500 patients, compared the efficacy of 3-month paliperidone palmitate in delaying the first occurrence of schizophrenia relapse symptoms with placebo.

Those treated with the investigational drug were stabilized with FDA-approved, once-monthly paliperidone palmitate (Invega Sustenna) prior to the start of the trial. The study was stopped early after the drug demonstrated a statistically significant difference from placebo in delaying time to relapse, with the research team concluding that the safety profile of 3-month paliperidone palmitate was consistent with that of Invega Sustenna.

If approved, 3-month paliperidone palmitate would be the first and only long-acting atypical antipsychotic with a dosing schedule of just 4 times annually.

“If approved, this 3-month formulation adds an unprecedented treatment option to help address the needs of people living with schizophrenia by providing a new, less frequently dosed treatment choice,” said Husseini K. Manji, MD, global head of the neuroscience therapeutic area at Janssen Research & Development, LLC, in a press release. “New treatments give patients, and caregivers, a broader range of options to address their needs as early as possible in their recovery journeys.”