FDA Accepts Submission for First 3-Month Long-Acting Schizophrenia Treatment

Meghan Ross, Associate Editor

On the heels of the FDA approval of paliperidone palmitate as either a monotherapy or adjunctive therapy for schizoaffective disorder, Janssen Pharmaceuticals, Inc, has submitted a new drug application for the medication's use as a 3-month atypical antipsychotic treatment for schizophrenia in adults.

On the heels of the FDA approval of paliperidone palmitate (Invega Sustenna) as either a monotherapy or adjunctive therapy for schizoaffective disorder, Janssen Pharmaceuticals, Inc, has submitted a new drug application for the medication’s use as a 3-month atypical antipsychotic treatment for schizophrenia in adults.

If approved, Invega Sustenna would be the first and only long-acting atypical antipsychotic administered only 4 times a year, according to Janssen.

In a phase 3 relapse prevention study that followed 500 patients, researchers compared 3-month injections of Invega Sustenna with placebo in delaying time to first occurrence of relapse symptoms, according to Janssen. Ultimately, it was determined that the safety profile of Invega Sustenna’s 3-month formulation was consistent with that of the once-monthly version, the company said.

Having a treatment option with fewer injections could help patients with schizophrenia maintain a healthy regimen, according to Janssen.

"Schizophrenia is often a devastating condition, and treatment interventions are needed early in the course of the disease," said Joseph A. Kwentus, MD, a psychiatrist and one of the clinical investigators in the 3-month formulation study. "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."

The most common side effects were injection site reactions, sedation, dizziness, akathisia, and extrapyramidal disorder.