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FDA Grants Priority Review for 3-Month Paliperidone Palmitate for Schizophrenia

New formulation improves on once-monthly Invega Sustenna

The FDA has granted “priority review” status for a 3-month formulation of the atypical antipsychotic drug paliperidone palmitate (Janssen) to treat schizophrenia in adults. If approved, it would be the first long-acting atypical antipsychotic that has a dosing schedule of only four times a year.

A “priority review” designation is given to investigational drugs that treat serious conditions and that, if approved, would provide a significant improvement in safety or efficacy. The designation means that the FDA’s goal is to take action on the marketing application for 3-month paliperidone palmitate within 6 months of the application’s receipt as opposed to 10 months under standard review.

The regulatory filing was based on data from a phase III, international, randomized, double-blind, relapse-prevention study of paliperidone palmitate 3-month injection. The study, which included more than 500 patients, evaluated the efficacy of 3-month paliperidone palmitate compared with that of placebo in delaying the first occurrence of relapse symptoms of schizophrenia. Patients who were randomly assigned to treatment were stabilized with Invega Sustenna (once monthly paliperidone palmitate, Janssen), an approved treatment for schizophrenia, before receiving the investigational 3-month formulation.

The study was stopped early for efficacy after an interim review of the results by an independent data monitoring committee found that the active treatment achieved a statistically significant difference from placebo in delaying the time to relapse.

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

Invega Sustenna (paliperidone palmitate) was approved by the 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. Late last year, the FDA approved the drug for the treatment of schizoaffective disorder, making it the only once-monthly medication to treat that condition.

Both Invega Sustenna and the new 3-month paliperidone palmitate formulation use the proprietary NanoCrystal technology (Alkermes), which allows the solubility of poorly water-soluble compounds.

Invega Sustenna is indicated for the treatment of 1) schizophrenia, and 2) schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants. The drug’s labeling includes a boxed warning regarding the potential for increased mortality in elderly patients with dementia-related psychosis.

Schizophrenia affects approximately 2.4 million U.S. adults, often beginning in the late teens or early 20s. If left untreated, the disease can interfere with education, employment, and interpersonal functioning. The course of schizophrenia is varied, generally involving a series of relapses (i.e., the return of disease after partial recovery).

Source: Johnson & Johnson; January 19, 2015.

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