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New Drug Application Submitted to FDA for 3-Month Paliperidone Palmitate (Invega Sustenna) for Schizophrenia

Once-monthly formulation approved in 2009

A new drug application (NDA) has been submitted to the FDA for a 3-month formulation of the atypical antipsychotic agent paliperidone palmitate (Invega Sustenna, Janssen Pharmaceuticals). The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, the new formulation of paliperidone palmitate will be the first long-acting atypical antipsychotic that has a four-times-a-year dosing schedule.

Schizophrenia affects approximately 1% of the U.S. population, often beginning in early adulthood. The course of the disease is varied, generally involving a series of relapses or the return of the disease after partial recovery.

The FDA filing was based on data from a phase III, international, randomized, double-blind study of 3-month paliperidone palmitate injection. The study, which included more than 500 patients, evaluated the efficacy of 3-month paliperidone palmitate compared with placebo in delaying the time to the first occurrence of relapse symptoms of schizophrenia.

Based on this study, the safety profile of the paliperidone palmitate 3-month formulation is consistent with that of once-monthly paliperidone palmitate (Invega Sustenna).

Patients with acute schizophrenia often do not have insight about the disease, which contributes to their not taking their medications or using treatment services. Medications, including daily pills or long-acting therapy, are the mainstay of treatment for symptoms. Relapses are often caused by not taking enough of or completely stopping a prescribed antipsychotic drug.

Paliperidone palmitate (Invega Sustenna) was approved by the FDA in July 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia. The drug’s efficacy was established in four short-term studies and in one longer-term study in adults.

Both the once-monthly and 3-month formulations of paliperidone palmitate use proprietary NanoCrystal technology (Alkermes), which enables the solubility of poorly water-soluble compounds.

Source: PR Newswire; November 19, 2014.

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