brexpiprazole / Generic mfg. - LARVOL DELTA

Population pharmacokinetic analysis and exposure-response analysis of brexpiprazole in Japanese patients with agitation in Alzheimer's dementia. (PubMed, Drug Metab Pharmacokinet) - "Therefore, brexpiprazole dose adjustment according to patient characteristics was not considered necessary in Japanese patients with AAD. Given the limited data and residual model instability in ER analysis, further investigation may be warranted to confirm the findings."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry • Schizophrenia

Treatment-resistant Parkinson's disease psychosis responding to xanomeline-trospium: A case report. (PubMed, Clin Park Relat Disord) - "He was referred specifically for a trial of clozapine therapy, which the patient and caregiver declined due to its risk profile. The patient's psychosis proved refractory to three pharmacologically distinct therapies-quetiapine, a low-affinity, rapidly dissociating dopamine D2 receptor antagonist; brexpiprazole, a dopamine D2 partial agonist; and pimavanserin, a selective 5-HT2A receptor inverse agonist-before improving with xanomeline-trospium, whose antipsychotic effects are mediated through central M1/M4 muscarinic receptor agonism. This case supports the further investigation of muscarinic receptor agonism as a therapeutic strategy for Parkinson's disease psychosis."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • DRD2

A Summary for Non-Psychiatrists of the Australian and New Zealand Journal of Psychiatry Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Guidelines for the Management of Schizophrenia. (PubMed, Med J Aust) - "A comprehensive yet tailored clinical assessment should be undertaken to identify treatable physical health comorbidities early, particularly for people with early psychosis. Pharmacotherapy should aim for the lowest effective dose with a tolerable and manageable adverse-effect profile (e.g., first-line pharmacotherapy with aripiprazole, brexpiprazole, cariprazine or lurasidone). Lifestyle interventions, particularly physical activity and multimodal lifestyle programmes, should be routinely offered to people with schizophrenia. Psychological and psychosocial interventions are essential components of care for people with schizophrenia, especially during the maintenance phase of illness. Clinicians should actively involve people with schizophrenia and their family, whānau and carers in shared decision-making. Comorbid psychiatric symptoms and conditions should be assessed and managed according to standard treatment approaches until more robust evidence base specific to..."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Differential effects of brexpiprazole on cognitive recovery and cortical volume after experimental traumatic brain injury. (PubMed, Brain Res) - "These findings demonstrate dose-specific behavioral and histological benefits of brexpiprazole following experimental TBI without detectable adverse effects on recovery. Although the mechanisms underlying these effects remain unclear, brexpiprazole warrants further investigation as a treatment option after TBI."

Journal • Anesthesia • CNS Disorders • Vascular Neurology

Interim data from ENIGMA – TRS 1 study of evenamide as add on therapy to antipsychotic Standard of Care in patients with treatment resistant schizophrenia (TRS). Difficulties in performing TRS study with TRRIP criteria: the CRO experience (WFSBP 2026) - "One aspect of the ENIGMA – TRS 1 study assesses plasma concentrations of standard of care as selected antipsychotics: Aripiprazole, Brexpiprazole, Cariprazine, Clozapine, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone and Ziprasidone for subjects treated with those antipsychotics with daily therapeutic doses meeting local product labels requirements and correlated those with minimal duration of 6 weeks treatment with any of those medications. As the study is performed in 20 countries worldwide major issues reside in getting approval by all regulatory approvals, languages use for the rating instruments as well as for the training of the raters. Based on hundreds of patients entering screening, a large proportion failed the screening phase because of lack of adequate concentration of the primary AP. Difficulties have been noticed in ensuring adequate documentation of previous AP failures."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Symptomatic treatment for Alzheimer disease: current evidence and future directions. (PubMed, Nat Rev Neurol) - "Established pharmacological treatments, notably cholinesterase inhibitors and memantine, deliver modest but significant benefits, with biomarker-stratified analyses suggesting the greatest benefit in individuals with confirmed AD pathology...Newer agents, including brexpiprazole for agitation and pimavanserin for psychosis, show promise but require careful interpretation of effect size and safety. Future progress will depend on biomarker-informed patient selection, integration of circuit-level measures, rational combination strategies spanning pharmacological and non-pharmacological modalities, and adoption of patient-centred outcomes. Symptomatic therapies will remain essential for improving quality of life in people with AD, even as disease-targeted therapies reshape disease trajectories."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Psychiatry

Increased Libido Following Brivaracetam Initiation: A Case Report of Temporal Lobe Epilepsy. (PubMed, Neuropsychopharmacol Rep) - "Previous reports have described increased libido with levetiracetam, which shares the same mechanism of action with BRV. Genetic factors, such as reduced striatal dopamine receptor density associated with DRD2/ANKK1 polymorphisms may contribute to psychiatric side effects. In this case, BRV-associated modulation of neurotransmission may have interacted with a vulnerable dopaminergic system, as indicated by the need for BXP. Preexisting bilateral hippocampal atrophy may also have provided a structural substrate resembling a pharmacologically induced incomplete Klüver-Bucy syndrome. Clinicians should be aware that patients may hesitate to report such symptoms and should actively monitor for changes in libido after initiating BRV."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Psychiatry • Sexual Disorders • DRD2

Brexpiprazole Treatment for Bipolar I Depression (clinicaltrials.gov) - P3 | N=58 | Recruiting | Sponsor: Douglas Mental Health University Institute | Trial completion date: Feb 2025 ➔ Dec 2030 | Trial primary completion date: Feb 2025 ➔ Sep 2030

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Partial Dopamine Agonists and Gambling Disorder: A Comprehensive Review and Clinical Implications. (PubMed, J Clin Psychopharmacol) - "The data presented suggest a clear relationship between aripiprazole and gambling behaviour, although more research is needed on this topic. Clinicians should be aware of the risk of gambling associated with partial dopamine agonists, and should therefore monitor the occurrence of gambling behaviour when introducing this drug, because patients may be reluctant to disclose it voluntarily."

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

Systematic review and network meta-analysis of the efficacy, safety and tolerability of xanomeline plus trospium chloride compared with eight oral antipsychotics for the acute treatment of schizophrenia. (PubMed, J Comp Eff Res) - "KarXT was associated with greater odds of clinical response (≥30% improvement in PANSS total score) than aripiprazole (odds ratio [OR]: 1.85; 95% credible interval [CrI]: 1.11, 3.11), brexpiprazole (OR: 2.23; 95% CrI: 1.34, 3.83) and cariprazine (OR: 2.05; 95% CrI: 1.19, 3.57); improved change from baseline (CFB) PANSS positive symptoms score versus brexpiprazole; improved CFB CGI-S score against aripiprazole, brexpiprazole, cariprazine and olanzapine; reduced odds of clinically significant (≥7%) weight gain over all comparators except clozapine (no data); improved CFB weight against brexpiprazole, clozapine, olanzapine, quetiapine and risperidone; and greater odds of all-cause discontinuation than aripiprazole, brexpiprazole, clozapine, lumateperone, olanzapine, quetiapine and risperidone. In this NMA, for patients receiving acute treatment for schizophrenia, KarXT compared favorably with second-generation antipsychotics on key efficacy endpoints and in terms of..."

Journal • Retrospective data • Anesthesia • CNS Disorders • Psychiatry • Schizophrenia

Reappraising lithium, triiodothyronine and second-generation antipsychotic augmentation treatment for major depression: a systematic review and meta-analysis with bias-adjustment analyses. (PubMed, BMJ Ment Health) - "The certainty and robustness of evidence for lithium and T3 augmentation remained limited. Evidence for T3 was sparse and did not show a significant advantage over control, while interpretation of the lithium findings is further constrained by the fact that most trials were conducted before treatment-resistant depression was more operationally defined in contemporary research. SGAs with TSA-supported benefits (aripiprazole, quetiapine, brexpiprazole and cariprazine) may be prioritised, pending individual patient considerations."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Dimensional effect profiles in treatment-resistant depression: A naturalistic, prospective head-to-head comparison of arTMS, esketamine nasal spray, and oral brexpiprazole. (PubMed, J Affect Disord) - "In routine clinical practice, ESK-NS, arTMS, and brexpiprazole were associated with short-term improvement in TRD, with exploratory signals of partially distinct symptom-domain profiles. These findings support the value of dimensional assessment in TRD and warrant confirmation in randomized studies with longer follow-up."

Head-to-Head • Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Brexpiprazole vs. Aripiprazole in Patients with Schizophrenia with or Without Comorbid Substance Use Disorder: A 12-Month Real-World Naturalistic Study of Efficacy. (PubMed, Brain Sci) - " Both dopamine partial agonists were effective in treating schizophrenia; however, brexpiprazole was superior in patients with comorbid SUD. Findings suggest that brexpiprazole may represent a promising therapeutic option in dual-disorder patients."

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

Adjunctive Pharmacotherapy for Major Depressive Disorder with Anxiety Symptoms: from Monoamines to Recent Clinical Evidence. (PubMed, CNS Drugs) - "Reviewed treatments included atypical antipsychotics (aripiprazole, brexpiprazole, olanzapine, quetiapine XR, risperidone, cariprazine), bupropion, ketamine/esketamine, lithium, mirtazapine/mianserin, modafinil, and triiodothyronine...Aripiprazole, brexpiprazole, quetiapine XR, and ketamine/esketamine have been shown to improve depression and/or anxiety symptoms in patients with MDD with anxiety symptoms, although evidence is mainly short-term and derived from exploratory post hoc analyses of trials not designed to assess anxiety outcomes. Treatment decisions for patients with MDD with anxiety symptoms should be based on robust clinical data, and there is an unmet need for prospective clinical trials with anxiety-specific endpoints in this patient population."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Brexpiprazole With Antidepressants for Agitation in Alzheimer's Dementia: Post Hoc Analysis. (PubMed, Am J Geriatr Psychiatry) - P3 | "In this exploratory post hoc analysis, brexpiprazole improved agitation symptoms and was generally well tolerated in participants with Alzheimer's dementia with and without concomitant antidepressants."

Clinical • Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

ETBREX: Single-case Intervention Study for Visual Screening Assessment for Proof of Concept and Prediction of Clinical Response to Brexiprazole as Adjunctive Treatment in Adults With Major Depressive Disorder. (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: University of Sao Paulo

New trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Quality by design-based continuous manufacturing of hot-melt extruded orodispersible films: online NIR-MSPC monitoring. (PubMed, Int J Pharm) - "A three-factor, three-level Box-Behnken design (BBD) was employed to optimize critical process parameters (CPPs) for hot-melt extruded brexpiprazole ODFs and delineate the design space...This elevated viscous dissipation likely promoted drug degradation, accounting for the increased impurity levels. Together, the integrated strategy combining design space definition, real-time process monitoring, and mechanistic simulation provides a systematic approach to quality assurance and process control in the continuous manufacturing of HME-processed ODFs."

Journal

Effects of Brexpiprazole on Functioning in Patients With Schizophrenia Who Have Hostility and Agitation Symptoms: Post Hoc Analysis of Short- and Long-Term Trials. (PubMed, J Clin Psychiatry) - P3 | " Brexpiprazole may improve functioning in adults with schizophrenia, even if they have hostility and agitation symptoms. Trial Registration: Data used in this post hoc analysis are from the following ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01397786, and NCT01810783."

Clinical • Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: New York State Psychiatric Institute

New P1 trial • CNS Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

Applicability of Regression Models for the Analysis of Ordinal PANSS Data in Schizophrenia: A Cohort Study. (PubMed, Consort Psychiatr) - "Statistical models designed to analyze continuous variables (linear and beta regression) are inapplicable for ordinal variables and, in particular, changes in schizophrenia symptoms over time on the PANSS. Beta-binomial and ordinal regression models are recommended for rating scores."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Evaluation of brexpiprazole as adjunctive therapy in treatment-resistant depression: Real-world data. (PubMed, Dusunen Adam) - "BRX may be an effective adjunctive treatment option for patients with TRD, with potential benefits for anxiety symptoms and overall functioning. Although some patients experienced weight gain, this effect did not appear to be clinically significant in our sample."

Journal • Real-world evidence • Anesthesia • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Fatty acid glyceride-based lipid microparticles as a long-acting injectable delivery system for brexpiprazole in schizophrenia treatment. (PubMed, J Mater Chem B) - "The therapeutic potential of this formulation was evaluated in a dizocilpine-induced rat model of schizophrenia. A single subcutaneous administration of BRE-GTS maintained therapeutic plasma levels and produced sustained antipsychotic effects for approximately two months, significantly ameliorating schizophrenia-like behaviors and improving cognitive performance. Overall, BRE-GTS represents a promising long-acting therapeutic approach for schizophrenia, combining favorable biosafety with sustained drug release, and holds substantial potential to improve medication adherence and long-term treatment outcomes."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Brexpiprazole Treatment in a Child With Autism Spectrum Disorder, Attention-Deficit/Hyperactivity Disorder (ADHD), and Trauma-Associated Hoarding Symptoms: A Case Report. (PubMed, Cureus) - "This case highlights the therapeutic challenges associated with managing complex neurodevelopmental conditions with multiple psychiatric comorbidities. These findings may provide insight into the interaction between neurodevelopmental vulnerability and trauma-related psychopathology and suggest a possible pharmacological consideration for treatment-resistant cases."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Mental Retardation • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Brexpiprazole and Quetiapine Use During Pregnancy and Lactation: A Case Report. (PubMed, Clin Case Rep) - "This case describes perinatal use of polypharmacy without apparent adverse maternal or infant outcomes, underscoring the need for individualized, risk-benefit-based decisions in perinatal psychiatry. Findings should be interpreted cautiously given the absence of standardized assessments and the concomitant use of quetiapine."

Journal • Psychiatry

Formulation, evaluation, and optimisation of soft chewable lozenges using Box-Behnken design for the treatment of schizophrenia. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Stability testing confirmed the stability of the optimised formulation throughout the study period. The optimised soft chewable brexpiprazole lozenges are a potential dosage form with improved patient acceptability, increased adherence, and improved systemic absorption, thus supporting its potential in the management of schizophrenia."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia