Invega Hafyera (Paliperidone Palmitate): Extended-Release Injectable Suspension for Patients With Schizophrenia

Abstract

Objective: The objective of this study was to describe the safety, efficacy, and potential role in therapy of once in 6 months paliperidone palmitate formulation (PP6M; Invega Hafyera). PP6M is a long-acting injectable antipsychotic recently approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. Data Sources: A PubMed literature search was conducted using the following terms: paliperidone palmitate and long-acting antipsychotic injections (January 1, 2017, to November 1, 2022). FDA product labeling was also reviewed for pertinent data. Study Selection and Data Extraction: All relevant English-language articles focused on the efficacy and safety of PP6M were considered for inclusion. Data Synthesis: A multicenter, randomized, active controlled relapse prevention noninferiority study showed that PP6M is comparable to paliperidone palmitate once in 3 months formulation (PP3M) in terms of efficacy and safety in clinically stable schizophrenia patients. Place in Therapy: PP6M is indicated in the treatment of adult patients with schizophrenia, who need treatment over a prolonged period. It improves adherence and decreases the rate of relapse and hospitalizations among patients with schizophrenia. It is useful for patients who may have difficulty accessing health care or would prefer the convenience of less frequent injections. Conclusion: PP6M with its long duration of action and lowered frequency of administration (once every 6 months) expands the therapeutic choices available to patients with schizophrenia. More studies in patients with schizophrenia with PP6M, and perhaps other mental illnesses (eg, schizoaffective disorder), are required to fully elucidate the therapeutic potential of PP6M.

Continuous Microfluidic Antisolvent Crystallization as a Bottom-Up Solution for the Development of Long-Acting Injectable Formulations

“…LAIs are primarily delivered through the intramuscular (IM) or subcutaneous (SC) routes as oil solutions, in situ forming gels, microspheres, implants, or micro- or nanosuspensions [ 3 , 10 , 11 ]. Owing to concerns over side effects, patient tolerance, and pain upon injection in most of the delivery systems, the micro- and nanosuspension technology has significantly advanced, and many of the more recent approved LAIs are either nano- or microsuspensions [ 4 , 12 , 13 ]. They are typically composed of poorly water-soluble BCS class II or IV APIs as micro- or nanocrystals, which are usually stabilized with one or more polymers and/or surfactants [ 14 ].…”