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Paliperidone palmitate intramuscular 6-monthly formulation in schizophrenia: a profile of its use

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Abstract

The 6-monthly formulation of intramuscular paliperidone palmitate [INVEGA HAFYERA™ (USA); BYANNLI® (EU)] represents a useful and convenient therapeutic option for patients with schizophrenia who have been adequately treated with or are clinically stable on the 1- or 3-monthly formulations of intramuscular paliperidone palmitate. As demonstrated in a randomized, double-blind, multicentre, phase 3 noninferiority trial, the efficacy of 6-monthly paliperidone palmitate is noninferior to that of 3-monthly paliperidone palmitate in terms of relapse rates in clinically stable patients. Both formulations were similarly effective in controlling symptom severity. Six-monthly paliperidone palmitate is generally well tolerated, with a safety and tolerability profile consistent with that of the 3-monthly formulation.

Plain Language Summary

Patients with schizophrenia often have poor adherence to antipsychotic medication. One approach to improve adherence is the use of long-acting injectable (LAI) antipsychotics that only need to be administered every few weeks or months, rather than daily. LAI antipsychotics are associated with better clinical outcomes, including lower rates of relapse, discontinuation and hospitalization. Paliperidone palmitate is an LAI formulation of the atypical antipsychotic paliperidone that is administered once a month or once every 3 months. A new 6-monthly formulation [INVEGA HAFYERA™ (USA); BYANNLI® (EU)] has recently been developed. In a phase 3 clinical trial, 6-monthly paliperidone palmitate was not inferior to the 3-monthly formulation in preventing relapse and improving symptoms. Six-monthly paliperidone palmitate was generally well tolerated and is a useful and convenient treatment option which may further improve medication adherence in patients with schizophrenia.

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Acknowledgements

The manuscript was reviewed by: J. Faden, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; S. Galderisi, University of Campania “Luigi Vanvitelli”, Naples, Italy. During the peer review process, Janssen, the marketing authorization holder of paliperidone palmitate, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

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H. A. Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Blair, H.A. Paliperidone palmitate intramuscular 6-monthly formulation in schizophrenia: a profile of its use. Drugs Ther Perspect 38, 335–342 (2022). https://doi.org/10.1007/s40267-022-00931-9

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