U.S. FDA approves Invega Trinza, first and only four-times-a-year treatment for schizophrenia

FDA

There’s a new treatment option for schizophrenia – Invega Trinza (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.

Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved under priority review the New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza.  Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia.  Before starting Invega Trinza, patients must be adequately treated with Invege Sustenna (one-month paliperidone palmitate) for at least four months. Priority review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

In a long-term maintenance trial, 93 percent of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. The results of the phase 3 study were published in March by JAMA Psychiatry, a peer-reviewed medical journal published by the American Medical Association. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC).

For more details, go to: http://www.jnj.com/news/all/US-FDA-Approves-INVEGA-TRINZA-First-and-Only-Four-Times-A-Year-Treatment-for-Schizophrenia

Michael Wonder

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Michael Wonder

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