Abilify Maintena (aripiprazole extended release) / Otsuka, BMS, Lundbeck - LARVOL DELTA

Considerations for Augmenting Aripiprazole Long-Acting Injectables with Other Antipsychotics: A Mini-Review. (PubMed, Diseases) - "Current literature on Ki values indicates that fluphenazine, pimozide, thiothixene, trifluoperazine, and perphenazine bind more strongly to dopamine D2 receptors than aripiprazole...Additionally, the muscarinic effects of aripiprazole suggest the possibility of augmentation with clozapine or xanomeline-trospium, albeit the peer-reviewed literature on this was also limited. Overall, it is difficult to draw conclusions regarding best clinical practices for these scenarios, as the existing literature is contradictory. Nonetheless, the application of the dopamine and muscarinic pathway theories for schizophrenia opens venues for future research and consideration."

Journal • Review • CNS Disorders • Psychiatry • Schizophrenia • DRD2

Better treatment outcomes with aripiprazole long-acting injection in community and incarcerated patients with serious mental illness. (PubMed, Front Psychiatry) - "Both groups experienced reduced hospitalizations and improvements in CGI-S scores and quality of life following aripiprazole LAI administration. Community patients showed a greater reduction in hospitalizations, while clinical and quality-of-life improvements were comparable across groups."

Journal • CNS Disorders • Mood Disorders • Personality Disorder • Psychiatry • Schizophrenia

Clinical Application of Aripiprazole Monohydrate Long-Acting Injectables for the Treatment of Schizophrenia: A Consensus Panel Report. (PubMed, J Clin Psychiatry) - "Two LAI formulations of aripiprazole monohydrate are available: aripiprazole once-monthly 400 mg and aripiprazole 2-month ready-to-use 960 mg, offering options to accommodate patient needs and preferences and support adherence. To support earlier and more informed use of aripiprazole monohydrate LAIs, a panel of psychiatric experts convened to review the latest evidence and share clinical strategies for integrating this agent into a comprehensive treatment plan. This Academic Highlights section presents the main points of their consensus recommendations, offering practical guidance for prescribers seeking to optimize outcomes in patients with schizophrenia."

Journal • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Exposure-Response Analysis for Aripiprazole Once-Monthly in Patients Diagnosed With Bipolar I Disorder. (PubMed, Clin Pharmacol Drug Dev) - "Plasma aripiprazole concentration was identified as an important predictor of recurrence in patients diagnosed with BP-I treated with AOM, highlighting the importance of maintenance therapy. A 95 ng/mL threshold is relevant in BP-I, but with a smaller effect size compared with that in schizophrenia."

Journal • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Pharmacokinetic evaluation of Aripiprazole Monohydrate as a once every 2-months long-acting injectable for schizophrenia. (PubMed, Expert Opin Drug Metab Toxicol) - "Aripiprazole Monohydrate (AM, Abilify Maintena®) was approved in 2013 as a monthly formulation, but a 2-month interval formulation (Ari2M, Abilify Asimtufii®) was approved by the FDA in 2023 for the treatment of schizophrenia in adults and maintenance monotherapy of Bipolar I disorder in adults, and by the EMA as Abilify Maintena® 960 mg in 2024 with the indication of maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. The new formulation employs a ready-to-use prefilled syringe, must be administered in the gluteal muscle, and can be given within ±2 weeks of the scheduled injection date. Reinitiation is only necessary if ≥14 weeks have passed since the prior injection."

Journal • PK/PD data • Review • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

The antipsychotics functional index (AFI) in schizophrenia. (PubMed, Front Pharmacol) - "The top-ranked antipsychotic is aripiprazole long-acting injection (LAI) administered every 2 months, 6 weeks, or 1 month, which is the only antipsychotic D2 partial agonist with an LAI formulation...The D2 partial agonist mechanism has a pharmacodynamic advantage. Based on this functionality index, psychiatrists could select the most suitable antipsychotic for each patient, with the ultimate goal of helping the patient achieve their maximum potential."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Addendum: Factors Affecting Continuation of Aripiprazole Long-acting Injection in the Real World. (PubMed, Clin Psychopharmacol Neurosci) - No abstract available

Journal • Real-world evidence

MainRexult: Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: The University of Hong Kong | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Two-Injection Start Regimen of Long-Acting Injectable Aripiprazole: Retrospective Data From a Tertiary Care Hospital in Turkey. (PubMed, Alpha Psychiatry) - "The AOM-TIS regimen enables the attainment of therapeutic plasma concentrations within a shortened timeframe, facilitating a more rapid clinical response. This approach may contribute to reduced healthcare costs by shortening the duration of hospitalization and enhancing patient adherence, supported by its favorable tolerability profile."

Journal • Retrospective data • Allergy • Bipolar Disorder • Cardiovascular • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - P2/3 | N=165 | Completed | Sponsor: The University of Hong Kong | Recruiting ➔ Completed | N=240 ➔ 165

Enrollment change • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Cost-utility of aripiprazole once-monthly versus paliperidone palmitate once-monthly injectable for schizophrenia in China. (PubMed, PLoS One) - "The cost-effectiveness of AOM relative to PP1M is highly influenced by its price and the CET. Healthcare decision makers or clinical users need to balance innovation incentives and accessibility."

Clinical • HEOR • Journal • CNS Disorders • Psychiatry • Schizophrenia

Long-term outcomes of Aripiprazole long-acting injectable: a 10-year mirror image study of patient acceptability and treatment effectiveness. (PubMed, Schizophrenia (Heidelb)) - "Its sustained use was associated with substantial reductions in hospital use, with 85% of completers requiring no further admissions, compared to 30% of discontinuers. These real-world findings support the long-term value of ALAI and may help address common barriers to LAI adoption in clinical decision-making."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Predictors of symptomatic and wellbeing remission in real-world samples of patients living with schizophrenia treated with aripiprazole once-monthly by means of constrained confidence partitioning. (PubMed, Schizophr Res) - "Despite only using a comparatively small sample, both logistic regression and c2p can produce reliable results with mathematically desirable properties. Patients with less severe core symptoms, better functioning, younger age, and better well-being may achieve symptomatic remission and remission of well-being more easily than other patients. The latter may need additional interventions in order to achieve remission."

Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Effectiveness of long-acting injectable aripiprazole on relapse prevention of bipolar I disorder (CINP-AsCNP 2025) - "Patients with a clinically unstable course of BPD may benefit from LAI aripiprazole; however, their prognosis is not as favorable as that of patients with a more stable course."

Bipolar Disorder • CNS Disorders • Psychiatry

Achieving Stability With Dual Long Acting Injectable Antipsychotic Medications in Treatment Resistant Psychosis a Case Series (APA 2025) - "The LAIs used were Invega (paliperidone) and Abilify (aripiprazole) in three cases, and Invega and Haldol (haloperidol) in the other three...In the other cases, Invega Sustenna and Abilify Maintena were used simultaneously...The cases in this series highlight LAIs as an important psychopharmacological tool in managing psychosis and potentially transitioning patients out of acute care settings, where they may otherwise be held for weeks, months, or years at a time due to safety concerns and/or a lack of appropriate resources. Furthermore, three of these cases support the use of two second-generation antipsychotics in combination as LAIs, which may be necessary to avoid severe side effects and the effects of long-term use commonly associated with first-generation antipsychotics."

Clinical • Bipolar Disorder • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Lundbeck raises financial guidance following strong start to the year with strategic brands growth of +24% CER (Lundbeck Press Release) - "The revenue of Lundbeck’s strategic brands increased by +24% CER (+28% DKK), reaching DKK 4,801 million, representing 77% of total revenue: Rexulti: DKK 1,491 million (+28% CER; +34% DKK); Brintellix/Trintellix: DKK 1,254 million (+7% CER; +7% DKK); Vyepti: DKK 1,042 million (+62% CER; +69% DKK); Abilify LAI franchise: DKK 1,014 million (+16% CER; +18% DKK)."

Sales • Major Depressive Disorder • Migraine • Schizophrenia

Real-world effectiveness of antipsychotic medication in relapse prevention after cannabis-induced psychosis. (PubMed, Br J Psychiatry) - "In particular, LAIs, clozapine and oral aripiprazole were associated with a decreased risk of psychosis relapse following CIP. Prescribers should consider using more LAIs for better treatment outcomes after CIP."

Journal • Real-world evidence • CNS Disorders • Psychiatry

Comparative modelling of foetal exposure to maternal long-acting injectable versus oral daily antipsychotics. (PubMed, NPJ Womens Health) - "This study employed physiologically based pharmacokinetic (PBPK) modelling to compare the extent of foetal exposure between oral and long-acting injectable (LAI) aripiprazole and olanzapine. Also, cumulative foetal exposure over 28 days from oral formulations were generally predicted to be lower compared with their therapeutic-equivalent LAI. As in utero foetal exposure to maternal drugs does not necessarily translate to risk, these data should be interpreted in a broader context that includes benefit-risk assessments."

Journal • CNS Disorders

Stability of psychotic symptoms and safety in switching to aripiprazole once-monthly according to prior oral antipsychotic drugs. (PubMed, Schizophr Res) - "Furthermore, AOM ameliorated psychotic symptoms without any significant adverse effect, regardless of their prior oral antipsychotics. However, patients previously treated with D2 antagonists may experience transient psychiatric TEAEs that can be minimized with longer cross-titration."

Journal • CNS Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Interaction Between Oxcarbazepine and Long-Acting Aripiprazole Leading to Relapse of Bipolar Disorder. (PubMed, Prim Care Companion CNS Disord) - No abstract available

Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Factors Affecting Continuation of Aripiprazole Long-acting Injection in the Real World. (PubMed, Clin Psychopharmacol Neurosci) - "This study supports the clinical effectiveness of aripiprazole LAI, demonstrated by a reduced one-year discontinuation rate compared to that observed in a paliperidone LAI study with a similar design. Large-scale, long-term prospective studies are essential to definitively ascertain the factors associated with LAI discontinuation."

Journal • Real-world evidence • CNS Disorders

Long-Standing Akathisia Associated With Long-Acting Injectable Aripiprazole: A Case Report. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal

Management of a Complex Case of Primary Enuresis in an Adult With Attention-Deficit Hyperactivity Disorder: A Case Report. (PubMed, Cureus) - "She was treated with 10 mg oral escitalopram once daily and a monthly intramuscular injection of 400 mg aripiprazole extended-release, with no reported improvement in her symptoms. Along with her current medications, she was started on 18 mg methylphenidate once daily and lamotrigine, started by 25 mg once daily, titrated to 50 mg. This adjustment led to significant improvement in her symptoms and the resolution of her enuresis. This case report demonstrates the resolution of ADHD symptoms along with the primary enuresis in an adult female patient who was treated with methylphenidate."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Bipolar Disorder • Borderline Personality Disorder • CNS Disorders • Mood Disorders • Personality Disorder • Psychiatry • Urinary Incontinence

C-Cog in Early Course Schizophrenia Study (clinicaltrials.gov) - P4 | N=60 | Terminated | Sponsor: University of Miami | Trial completion date: Jul 2025 ➔ Mar 2025 | Recruiting ➔ Terminated; Recruitment issues

Trial completion date • Trial termination • CNS Disorders • Psychiatry • Schizophrenia

Liver dysfunction and long-acting aripiprazole: The importance of tolerability assessment. (PubMed, Int J Clin Pharmacol Ther) - No abstract available

Journal • Hepatology • Liver Failure