FDA Grants Priority Review to Schizophrenia Treatment

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.”