title: New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base.
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.
authors.affiliation: Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry,University of Verona,Verona,Italy.
authors.forename: G
authors.initials: G
authors.lastname: Ostuzzi
authors.affiliation: Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry,University of Verona,Verona,Italy.
authors.forename: D
authors.initials: D
authors.lastname: Papola
authors.affiliation: Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry,University of Verona,Verona,Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gastaldon
authors.affiliation: Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry,University of Verona,Verona,Italy.
authors.forename: C
authors.initials: C
authors.lastname: Barbui
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000066491:Clinical Decision-Making; D005060:Europe; D055317:Evidence-Based Practice; D006291:Health Policy; D006801:Humans; D007267:Injections; D000068882:Paliperidone Palmitate / Q000008:administration & dosage* / Q000627:therapeutic use; D058028:Research Report; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D000068882:Paliperidone Palmitate
keywords: Antipsychotics; evidence-based psychiatry; psychosis; research design and methods