New Paliperidone Formulation Approved: Invega Trinza

SOURCE: Psychopharmacology Institute
Dr. Flavio Guzman

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The US FDA recently approved a new paliperidone formulation: Invega Trinza. This is a 3-month injection that allows a longer dosing interval.

• Brand name: Invega Trinza
• Approval date: May 18, 2015
• Indication: Treatment of schizophrenia in patients after they have been adequately treated with 1-month paliperidone palmitate extended-release injectable suspension (Invega Sustenna) for at least four months
• Efficacy trial that led to FDA approval [1] : One randomized, multicenter trial with N=506 patients, measured in main outcome : time to relapse

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Prescribing information [2]

• Use Invega Trinza only after the patient has been adequately treated with the 1-month paliperidone palmitate extended-release injectable suspension for at least four months
• Should be administered once every 3 months.

Initiate INVEGA TRINZA™ when the next 1-month paliperidone palmitate dose is scheduled with an INVEGA TRINZA™ dose based on the previous 1-month injection dose as shown below.

References

1. Berwaerts, J., Liu, Y., Gopal, S., Nuamah, I., Xu, H., Savitz, A., … & Hough, D. W. (2015). Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA psychiatry  
2. Invega Trinza (paliperidone palmitate) extended-release injectable suspension. [Prescribing Information]. Titusville, NJ Janssen Pharmaceuticals, Inc. Accessed May 2015