Maintena

BACKGROUND: ReLiAM, Real-Life Assessment of Abilify Maintena, was the first reported long-term prospective non-interventional study for patients with schizophrenia treated with aripiprazole once-monthly injectable formulation (AOM) under real-life conditions. ReLiAM's primary aim was to evaluate the evolution of global functional status in patients treated with AOM for 12 months in Canada. METHODS: The objective of this post hoc analysis of the ReLiAM study is to investigate the treatment effects of real-life use of AOM over a 1-year period in the subgroup of patients with reported substance use compared with patients without substance use...

BACKGROUND: Treatment of schizophrenia requires long-term medication to prevent relapse. Treatment nonadherence may increase the risk of relapse, leading to increased hospitalizations and emergency room (ER) visits. Long-acting injectables (LAIs) such as paliperidone palmitate have improved treatment adherence and therefore symptoms. However, real-world studies comparing 3-monthly LAI formulations with other LAIs and oral antipsychotics (OAs) are scarce. OBJECTIVE: The objective of this study was to investigate and evaluate the clinical effectiveness of paliperidone palmitate LAI monthly (PP1M; Xeplion® ) and 3-monthly (PP3M; Trevicta® ) formulations compared with the monthly LAI aripiprazole (AM; Abilify Maintena® ) and OAs in Spain...

An intramuscular formulation of aripiprazole monohydrate dosed once monthly (AOM) was developed to address nonadherence with the approved oral tablets. A 3-compartment linear population pharmacokinetic model for oral and AOM doses was developed; relative bioavailability was estimated for AOM relative to oral dosing and body mass index and sex were significant predictors of AOM absorption rate constant (longer absorption half-life for women and absorption half-life increases with increasing body mass index)...

This study aims to explore the influence of wet milling and jet pulverization on the aripiprazole microcrystalline long-acting injection. Crystal form and particle size distribution were taken as inspection indicators in vitro, and process parameters were optimized. The formulation prepared by wet milling (AMLAI-WM) was shown to undergo a slight conversion of crystal form by DSC, PXRD, TG, FT-IR and have a wider particle size distribution with D50 and Span values of 2.967 μm and 3.457 compared to the formulation fabricated by jet pulverization (AMLAI-JP) with 2...

INTRODUCTION: Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serotonin 5-HT1A agonism and antagonism at serotonin 5-HT2A receptors. AREAS COVERED: We review short-and-long-term clinical trials, meta-analyses of clinical trials and product information pertaining to the safety and efficacy of aripiprazole in adults with schizophrenia...

Objective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena® ) on symptom stability in acute treatment and maintenance therapy settings in patients with schizophrenia. Methods: Results were analyzed from two pivotal maintenance studies (Studies 246 and 247), a long-term (52 weeks), open-label extension of these studies (Study 248), an open-label, mirror-image study in patients switching from oral to long-acting injectable antipsychotic therapy (Study 283), and a study of AOM 400 in the acute setting (Study 291)...

OBJECTIVE: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena® ) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings. METHODS: Post hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy...

BACKGROUND: With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada. METHODS: Following their clinicians' decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings...

This work describes the preparation of aripiprazole sustained-release microcrystals for intramuscular injection, through recrystallization, drying, wet grinding, and solidification steps, which had a great impact on the product quality. Here, we evaluated the crystal form of the drug in each step by differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and fourier transform infrared spectroscopy (FT-IR), demonstrating that there is no change in the crystal form of aripiprazole monohydrate (H1) during grinding and freeze-drying...

OBJECTIVES: The aim of this study is to provide an opinion paper reviewing the role of depot or long-acting injectable (LAI) antipsychotic medications, with comments on individual newer LAIs such aripiprazole maintena and paliperidone palmitate. In particular, we share our recent experience of using paliperidone three-monthly LAI. We also reflect on the associated benefits and potential harms of LAIs, and when they may be used. CONCLUSIONS: LAI antipsychotics are an important and arguably under-utilised therapeutic option, particularly where medication adherence is a priority, and where an informed patient opts for this formulation...

BACKGROUND: The concept of dose equivalence of depot medication is important for many scientific and clinical purposes. METHODS: A systematic literature search on four second-generation antipsychotics available as long-acting injectable drugs and haloperidol was conducted. We used the minimum effective dose method which is based on randomized fixed dose studies where the smallest dose which was significantly more efficacious than placebo in the primary outcome was declared as minimum effective dose...

Schizophrenia presents a substantial clinical and economic burden to the health-care system. In QUAlity of LIfe with AbiliFY Maintena (QUALIFY), a randomized head-to-head study of aripiprazole once-monthly 400 mg (AOM 400) compared with paliperidone palmitate (PP; 78-234 mg/mo), AOM 400 demonstrated greater improvement in health-related quality of life and functioning in patients with stable schizophrenia. The present analysis used health economics assessment data collected during the QUALIFY study to determine the direct medical and pharmacy costs and the cost-effectiveness associated with each treatment over 6 months...

Relapse in schizophrenia has been associated with poor adherence to oral medication. A possible method to optimize medication adherence could be to switch patients from oral to depot medication. In this respect, aripiprazole long acting injectable (ALAI) significantly delayed time to impending relapse when compared with placebo (p < 0.0001), while ALAI was generally well tolerated during both short-term and long-term studies. A literature search, using PubMed was conducted to identify relevant publications...

Relapse in schizophrenia has been associated with poor adherence to oral medication. A possible method to optimize medication adherence could be to switch patients from oral to depot medication. In this respect, aripiprazole long acting injectable (ALAI) significantly delayed time to impending relapse when compared with placebo (p < 0.0001), while ALAI was generally well tolerated during both short-term and long-term studies. A literature search, using PubMed was conducted to identify relevant publications...

Aripiprazole (ABILIFY(®)) is an atypical antipsychotic drug that is proposed to act via partial agonism of dopamine D2 receptors. Trials with oral aripiprazole have shown that, compared with some other atypical antipsychotics, aripiprazole is associated with fewer metabolic disturbances and has a favourable cardiovascular tolerability profile. Recently, an intramuscular long-acting injectable (LAI) depot formulation of aripiprazole (ABILIFY MAINTENA(®)) (aripiprazole LAI) has been approved for use as a treatment for schizophrenia in adults...

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Schizophrenia is a severe mental illness with a lifetime prevalence of approximately one percent worldwide. Maintenance antipsychotic treatment has been effective in preventing relapses in long-term follow-up studies. Logically it can be proposed that long-acting injectable antipsychotics (LAI) might reduce both unintentional and intentional nonadherence. Long-acting injectable aripiprazole was approved for the treatment of schizophrenia by the U.S. FDA on 28th February 2013 and will be marketed under the name Abilify Maintena...

Isolated cat submandibular glands were perfused with Locke solutions in a thermostated chamber. Passive loss of potassium and uptake of sodium was achieved either by increasing the permeability of the cell membranes by acetylcholine (ACh) or by inhibiting the sodium-potassium pump reversibly by cooling or by removal of extracellular potassium. Irrespective of the way by which the cells were potassium depleted and sodium loaded, re-establishment of normal conditions was sufficient to cause an active net uptake of potassium (probably coupled to net extrusion of sodium)...