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Cambridge University Press, Epidemiology and Psychiatric Sciences, 3(26), p. 231-233, 2016

DOI: 10.1017/s2045796016001025

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New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base

Journal article published in 2016 by G. Ostuzzi, D. Papola ORCID, C. Gastaldon ORCID, C. Barbui
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Three-month long-acting paliperidone is a new, recently marketed, formulation of paliperidone, characterised by the longest available dosing interval among long-acting antipsychotics. The clinical profile of 3-month long-acting paliperidone was recently summarised by the European Medicines Agency (EMA) in a public assessment report, released in April 2016. In this commentary, the main strengths and limitations of the EMA assessment report were appraised and discussed, in order to highlight possible implications for clinical practice, future research and regulatory practices for drug approval.