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

Author:

Ostuzzi G.,Papola D.,Gastaldon C.,Barbui C.

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.

Publisher

Cambridge University Press (CUP)

Subject

Psychiatry and Mental health,Public Health, Environmental and Occupational Health,Epidemiology

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