Janssen Research & Development has submitted a new drug application (NDA) for its three-month atypical antipsychotic paliperidone palmitate to the US Food and Drug Administration (FDA).
The company filed an application seeking approval to treat complex and chronic brain disorder, schizophrenia, in adults.
Janssen Research & Development neuroscience therapeutic area global head Husseini Manji said: "This innovative three-month formulation has the potential to positively affect the care of many people with schizophrenia.
"The option for this dosing schedule would offer a welcome new choice for patients and may provide benefits to society."
The company submitted NDA based on a Phase III international, randomised, multicentre, double-blind, relapse prevention study of paliperidone palmitate three-month injection.
Approximately 500 patients were included in the study, which assessed the efficacy of three-month paliperidone palmitate compared with a placebo in delaying time to first occurrence of relapse symptoms of schizophrenia.
Hinds Behavioral Health Services psychiatrist and clinical investigator in the Phase III paliperidone palmitate three-month formulation study Joseph Kwentus said: "Psychotherapy, medication, and community support can help people with schizophrenia better manage their illness."
The drug will be the first and only long-acting atypical antipsychotic with four times a year dosing schedule, if approved by the FDA.
Schizophrenia affects 1% of the population, often beginning in early adulthood and it can interfere with education, employment, and interpersonal functioning, if untreated.
Invega Sustenna (paliperidone palmitate) received FDA approval in July 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia. It also received approval for use in 80 countries.
Image: Image showing brain areas more active in controls than in schizophrenia patients during a working memory task during an fMRI study. Photo: courtesy of Kim J, Matthews NL, Park S.
