The US Food and Drug Administration (FDA) has granted Priority Review status for Janssen's New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a dosing schedule of just four times a year.
Priority Review is a designation for a drug that treats a serious condition and, if approved, would provide significant improvement in safety or effectiveness. A priority review designation means FDA's goal is to take action on the marketing application within six months of receipt as compared to 10 months under standard review.
"If approved, this three-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, neuroscience therapeutic area, Janssen Research & Development. "New treatments give patients, and caregivers, a broader range of options to address their needs as early as possible in their recovery journeys."
Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It affects approximately 2.4 million U.S. adults, often beginning in the late teens or early 20s. If left untreated, schizophrenia can greatly interfere with education, employment and interpersonal functioning. The course of schizophrenia is varied, generally involving a series of relapses or the return of disease after partial recovery.
The filing was based on a phase 3, international, randomised, multicentre, double-blind, relapse prevention study of paliperidone palmitate three-month injection. The study, which included more than 500 patients, evaluated the efficacy of three-month paliperidone palmitate compared with placebo in delaying time to first occurrence of relapse symptoms of schizophrenia. Study patients who were randomised to treatment were stabilised with Invega Sustenna (once monthly paliperidone palmitate), an approved treatment for schizophrenia, prior to receiving the investigational three-month formulation. The study was stopped early for positive efficacy after an interim review of the data by an Independent Data Monitoring Committee based on pre-specified criteria, specifically achieving a statistically significant difference from placebo in delaying time to relapse. Based on this study, the safety profile of paliperidone palmitate three-month formulation is consistent with that of once monthly Invega Sustenna.
Invega Sustenna (paliperidone palmitate) was approved by the US FDA in July 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries. Late last year the FDA approved Invega Sustenna for the treatment of schizo affective disorder, making it the first and only once-monthly medication to treat this condition.
Invega Sustenna and three-month paliperidone palmitate utilise Alkermes' proprietary NanoCrystal technology, which enables solubility of poorly water-soluble compounds.