The Food and Drug Administration has approved the long-acting atypical antipsychotic Invega Trinza (3-month paliperidone palmitate) to treat schizophrenia, Janssen Pharmaceuticals announced May 19.
Invega Trinza is the first schizophrenia drug to be injected just four times per year, in 3-month intervals, and was approved under FDA priority review, the company said in a statement.
Before starting treatment with Invega Trinza, patients must first be treated with Invega Sustenna (paliperidone palmitate) for at least 4 months.
In a phase III trial recently published in JAMA Psychiatry, time to relapse was significantly delayed in patients who received Invega Trinza, compared with those on placebo (hazard ratio, 3.45; 95% confidence interval, 1.73-6.88; P <.001). Of patients treated with Invega Trinza, 93% did not experience a significant return of schizophrenia symptoms.
“With this new treatment option, health care providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan,” Janssen said in the statement.
Invega Trinza may cause serious side effects, including increased risk of death in elderly patients with confusion, memory loss, or dementia-related psychosis. For more safety information, please visit http://www.janssenmd.com/pdf/invega-trinza/invega-trinza_pi.pdf.
Bron: Clinical Psychiatry