A new paliperidone palmitate formulation: how is it different and where does it fit in our array of choices for long-acting formulations of risperidone and paliperidone?

Abstract

Long-acting injectable (LAI) antipsychotics have been shown to enhance treatment adherence and outcomes in individuals with schizophrenia, schizoaffective disorder, and bipolar disorder. In recent years, the U.S. Food and Drug Administration (FDA) has approved several LAIs with differing amenities of care, such as mode of administration, duration of oral medication supplementation, dosing frequency, needle gauge and size, and injection volume, amongst others. Additionally, several LAIs are distinct formulations of risperidone and paliperidone, making it difficult to distinguish between formulations, and many providers are unfamiliar with these newer agents. In 2024, a once-monthly LAI formulation of paliperidone palmitate, manufactured by Luye (PP1M Luye), was approved for the treatment of schizophrenia and schizoaffective disorder. There are similarities and differences between PP1M (Luye) and once-monthly paliperidone palmitate manufactured by Janssen (PP1M Janssen), which was FDA approved in 2009. The focus of this commentary will be to identify common characteristics and differences between these competing formulations, as well as how they relate to the overall compendium of risperidone and paliperidone LAI antipsychotic formulations.