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FDA Approves Invega Trinza (Paliperidone Palmitate)

First four-times-a-year treatment for schizophrenia

The FDA has given the green light to the long-acting atypical antipsychotic Invega Trinza (paliperidone palmitate, Janssen Pharmaceuticals). The product, a 3-month injectable suspension for intramuscular use, is indicated to treat schizophrenia.

Before starting Invega Trinza, patients must be adequately treated with once-a-month Invega Sustenna for at least 4 months.

A long-term, phase III maintenance trial evaluated the efficacy and safety of the 3-month formulation of paliperidone palmitate compared with placebo in delaying the time to relapse of schizophrenia symptoms. This randomized study consisted of four phases: a 3-week screening phase; a 17-week, flexible-dose, open-label transition phase; a 12-week, open-label maintenance phase; and an open-ended double-blind phase. A total of 305 patients (aged 18 to 70 years) were randomly assigned to receive 3-month paliperidone palmitate (n = 160) or placebo (n = 145) in the double-blind phase.

In an interim analysis, the time to first relapse was significantly different in favor of the paliperidone palmitate group compared with the placebo group (hazard ratio, 3.45; P < 0.001); the median time to relapse was 274 days for placebo but was not estimable for 3-month paliperidone palmitate.

Of the patients treated with Invega Trinza, 93% did not experience a significant return of schizophrenia symptoms.

In the double-blind phase of the study, 183 of the 305 patients (62% with 3-month paliperidone palmitate; 58% with placebo) had at least one treatment-emergent adverse event; those noted more frequently in the group receiving paliperidone palmitate than in the placebo group included headache (9% vs. 4%, respectively), increased weight (9% vs. 3%), nasopharyngitis (6% vs. 1%), and akathisia (4% vs. 1%).

Based on the positive efficacy findings, Janssen concluded this study early following the recommendation of an independent data-monitoring committee. The results were published in the March 2015 issue of JAMA Psychiatry.

Janssen anticipates that Invega Trinza will be commercially available by mid-June.

Schizophrenia affects approximately 2.4 million adults in the U.S, often beginning in early adulthood, just as individuals are establishing their independence. The course of schizophrenia is varied, frequently involving periodic relapses of the disease with sometimes an incomplete response to treatment. Each relapse can result in a reduced response to treatment, putting continued symptom control even further out of reach.

Sources: Janssen Pharmaceuticals; May 19, 2015; Invega Trinza Prescribing Information; May 2015; and JAMA Psychiatry; March 29, 2015.

 

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