Janssen submits NDA for three-month paliperidone palmitate to treat schizophrenia in US

The NDA was based on an international, randomized, multicenter, double-blind, relapse prevention Phase III trial of paliperidone palmitate three-month injection.

More than 500 patients were included in the trial, which evaluated the efficacy of three-month paliperidone palmitate compared with placebo in delaying time to first occurrence of relapse symptoms of schizophrenia.

If approved by the FDA, the product will be the first and only long-acting atypical antipsychotic that has four times a year dosing schedule.

Janssen Research & Development global head of Neuroscience Therapeutic Area 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."

Schizophrenia affects about one percent of the population, often beginning in early adulthood and if left untreated, it can greatly interfere with education, employment, and interpersonal functioning.

Hinds Behavioral Health Services psychiatrist and clinical investigator in the Phase III paliperidone palmitate three-month formulation trial Joseph Kwentus said: "Psychotherapy, medication, and community support can help people with schizophrenia better manage their illness. It’s important that medical professionals, policy makers, and patients’ loved ones support comprehensive treatment."

Based on the Phase III trial, the safety profile of paliperidone palmitate three-month formulation is consistent with that of once-monthly INVEGA SUSTENNA (paliperidone palmitate).

Image: The NDA was based on a Phase III trial of paliperidone palmitate three-month injection. Photo courtesy of Baitong333/ freedigitalphotos.net.