Janssen announces submission of NDA for three-month paliperidone palmitate

Janssen Research & Development, LLC (Janssen) today announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to the U.S. Food and Drug Administration (FDA). The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.

"This innovative three-month formulation has the potential to positively affect the care of many people with schizophrenia," said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "The option for this dosing schedule would offer a welcome new choice for patients and may provide benefits to society."

Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It affects approximately one percent of the population, often beginning in early adulthood. 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.

"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 at Hinds Behavioral Health Services, Jackson, Miss., who was a clinical investigator in the Phase 3 paliperidone palmitate three-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 filing was based on a Phase 3, international, randomized, multicenter, 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.

In March 2014, Janssen announced that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it halted the Phase 3 clinical study of paliperidone palmitate three-month formulation early. The recommendation to stop and unblind the clinical study at the interim analysis was made by the IDMC 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^® (paliperidone palmitate). The full study results will be presented at future medical congresses and are being submitted for publication in a peer-reviewed journal.

While there is no cure for the illness, individuals with schizophrenia, working with their treatment teams, can lead meaningful lives with a treatment regimen that may include medication, psychotherapy, and other interventions. Patients with acute illness often do not have insight about schizophrenia, which contributes to their not taking medication or using treatment services. Medication, including daily pills or long-acting therapy, is the mainstay of treatment for symptoms. Relapses are often caused by not taking enough of or completely stopping prescribed antipsychotic medication.

INVEGA^® SUSTENNA^® (paliperidone palmitate) was approved by the U.S. 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. Efficacy was established in four short-term studies and one longer-term study in adults. Janssen Pharmaceuticals, Inc. markets INVEGA SUSTENNA in the United States.

INVEGA^® SUSTENNA^® and three-month paliperidone palmitate utilize Alkermes' proprietary NanoCrystal^® technology, which enables solubility of poorly water-soluble compounds.