Evaluating the 6-month formulation of paliperidone palmitate: a twice-yearly injectable treatment for schizophrenia in adults

ABSTRACT

Introduction

Paliperidone Palmitate is the only antipsychotic that has been developed in three different intramuscular long-acting injectable (LAI) dosing regimen: monthly (PP1M), quarterly (PP3M), and from 2020 also twice-yearly (PP6M). The latter was approved for the maintenance treatment of adults with schizophrenia and clinically stabilized with PP1M or PP3M.

Areas covered

Data from studies evaluating efficacy in the maintenance treatment of schizophrenia with PP6M are reviewed. Since no post-marketing safety studies are currently available, data from spontaneous reporting system databases, FAERS and Eudravigilance, are analyzed and the reported treatment-emergent adverse events of PP6M are discussed.

Expert opinion

The efficacy of PP6M is comparable to that of PP3M in terms of relapses prevention in patients with schizophrenia previously stabilized on PP3M or PP1M. Also, the maintenance of clinical efficacy in the long term has been demonstrated. Data from pharmacovigilance analyses, as well as from phase 3 studies, show that PP6M is generally well tolerated, consistently with PP3M safety data. PP6M allows a longer dosing interval than any other LAI antipsychotics, potentially reducing nonadherence and disease relapses. In future, an increase in the prescription rates of PP6M is expected and real-world efficacy and tolerability studies will be conducted.

KEYWORDS:

• Adherence
• antipsychotics
• long-acting injectable formulation
• paliperidone palmitate
• psychosis
• schizophrenia
• six-months
• twice yearly

Article highlights

• Long-acting injectable (LAI) antipsychotics are essential in the treatment of schizophrenia in adult with poor adherence to oral medication

• PP6M is the only LAI antipsychotics available in a twice-yearly formulation

• PP6M has shown to be as efficacious as PP3M in terms of relapses prevention in patients with schizophrenia

• PP6M is generally well-tolerated with a predictable adverse event profile.

• The authors anticipate, in the future, that the prescription rates of PP6M will increase, which will enable real world efficacy and tolerability studies to be conducted.

Declaration of interest

B Dell’Osso has received honoraria for lectures, unrelated to this work, from Angelini, Janssen Pharmaceuticals, Lundbeck, Livanova, Arcapharma, and Neuraxpharm. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One reviewer declares grant support from BioXcel Therapeutics. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.