Janssen Pharmaceuticals Receives FDA Approval for INVEGA TRINZA Schizophrenia Treatment

Janssen Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) has approved, under priority review, the new drug application for the three-month long-acting anti-psychotic INVEGA TRINZA™.

As quoted in the press release:

INVEGA TRINZA™, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting INVEGA TRINZA™, patients must be adequately treated with INVEGA 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).

Click here to read the full Janssen Pharmaceuticals Inc. press release.