FDA approves Invega Trinza (three month paliperidone palmitate) to treat schizophrenia-Janssen Pharma

Janssen Pharmaceuticals, Inc. announced that the 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 Invega Sustenna (one-month paliperidone palmitate) for at least four months. In a long-term maintenance trial, 93 percent of patients treated with Invega Trinza didnot 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).

See-"Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial"- Joris Berwaerts, MD; Yanning Liu, MS; Srihari Gopal, MD, MHS; Isaac Nuamah, PhD; Haiyan Xu, PhD; Adam Savitz, MD, PhD; Danielle Coppola, MD; Alain Schotte, PhD; Bart Remmerie, Chem Eng; Nataliya Maruta, MD, PhD; David W. Hough, MD- JAMA Psychiatry. 2015; doi: 10.1001/jamapsychiatry.2015.0241.

Comment: The purpose of the three month formulation is to improve adherence rates as failure to adhere to the treatment leads to relapse.