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Matthew Sussman, Jeffrey Yu, Siddhesh A Kamat, Ann Hartry, Susan Legacy, Ruth Duffy, Myrlene Sanon Aigbogun
BACKGROUND: Major depressive disorder (MDD) is a debilitating psychiatric illness with a high cost burden. This analysis evaluates the cost-effectiveness of adjunctive brexpiprazole versus comparator branded adjunctive treatment for MDD and background antidepressant therapy (ADT) alone from a US payer perspective. METHODS: An economic model was developed to assess the cost-effectiveness of brexpiprazole versus comparator adjunctive treatment and ADT alone on total direct medical costs using a 6-week cycle time frame for a total of 48 weeks, with treatment response and remission as primary outcomes...
September 20, 2016: Journal of Affective Disorders
Sheng-Min Wang, Changsu Han, Soo-Jung Lee, Tae-Youn Jun, Ashwin A Patkar, Prakash S Masand, Chi-Un Pae
Less than one third of patients who suffer from major depressive disorder (MDD) report remission following antidepressant treatments requiring more diverse treatment approaches. Augmentation of second generation antipsychotics (SGAs) has been increasingly recognized as an important treatment option. The authors have previously provided a comprehensive review of SGAs for the treatment of MDD in 2013. Since then, numerous additional clinical trials have been conducted to investigate diverse issues regarding the utility of SGAs in MDD...
September 2016: Chonnam Medical Journal
Jonathan R Scarff
Schizophrenia occurs in approximately 0.3 to 0.7 percent of the world's population and is associated with significant morbidity and mortality. Although atypical antipsychotics reduce positive and negative symptoms, they are associated with varying degrees of metabolic adverse effects. This necessitates continued development of efficacious yet metabolically favorable treatments. This article reviews brexpiprazole, a medication recently approved to treat patients with schizophrenia. Brexpiprazole was well-tolerated, and adverse reactions were statistically insignificant...
July 2016: Innovations in Clinical Neuroscience
Ashok Malla, Ai Ota, Kazuhiro Nagamizu, Pamela Perry, Emmanuelle Weiller, Ross A Baker
The aim of this study was to evaluate flexibly dosed brexpiprazole for early-episode schizophrenia through the assessment of efficacy, social functioning, and tolerability. This was an exploratory, 16-week, open-label, flexible-dose (1, 2, 3, or 4 mg/day; target dose 3 mg/day) study in outpatients with early-episode schizophrenia (18-35 years old, ≤5 years' duration of illness). Efficacy was assessed by the Positive and Negative Syndrome Scale score (PANSS) and social functioning was assessed by changes from baseline in PANSS modified prosocial subscale, personal and social performance (PSP), and specific levels of functioning (SLOF) scales...
November 2016: International Clinical Psychopharmacology
W Wolfgang Fleischhacker, Mary Hobart, John Ouyang, Andy Forbes, Stephanie Pfister, Robert D McQuade, William H Carson, Raymond Sanchez, Margareta Nyilas, Emmanuelle Weiller
BACKGROUND: Brexpiprazole has previously demonstrated efficacy in acute schizophrenia trials. The objective of this trial was to assess the efficacy, safety, and tolerability of maintenance treatment with brexpiprazole in adults with schizophrenia. METHODS: Patients with an acute exacerbation of psychotic symptoms were converted to brexpiprazole (1-4mg/d) over 1 to 4 weeks and entered a single-blind stabilization phase. Those patients who met stability criteria for 12 weeks were randomized 1:1 to double-blind maintenance treatment with either brexpiprazole (at their stabilization dose) or placebo for up to 52 weeks...
October 13, 2016: International Journal of Neuropsychopharmacology
Michael E Thase
Over the past decades, several adjunctive therapies have been introduced for treatment-resistant depression (TRD), and these strategies have ebbed and flowed in popularity. Currently, adjunctive therapy with the second-generation antipsychotics (SGAs) is most commonly used by psychiatrists. Four SGAs are FDA approved for indications related to TRD (aripiprazole, brexpiprazole, olanzapine, and quetiapine extended release); some evidence also supports use of risperidone and ziprasidone as adjunctive therapies...
September 2016: Psychiatric Clinics of North America
Shannon Eaves, Jose A Rey
Brexpiprazole (Rexulti): a new monotherapy for schizophrenia and adjunctive therapy for major depressive disorder.
July 2016: P & T: a Peer-reviewed Journal for Formulary Management
Maurizio Fava, François Ménard, Charlotte Kampp Davidsen, Ross A Baker
OBJECTIVE: To evaluate the effects of adjunctive brexpiprazole on symptoms of irritability in patients with major depressive disorder (MDD). METHODS: Patients diagnosed with MDD according to DSM-IV-TR criteria who had inadequate response to antidepressant treatment continued treatment with their current antidepressant for 2 weeks. Patients still having inadequate response, and with irritability, received 6 weeks of open-label treatment with their current antidepressant at the same dose and adjunctive brexpiprazole (target dose: 3 mg/d)...
July 5, 2016: Journal of Clinical Psychiatry
Fang Fang, Hongwei Sun, Zuowei Wang, Ming Ren, Joseph R Calabrese, Keming Gao
Somnolence is a common side effect of antipsychotics. To assess the incidence of this side effect, we performed a MEDLINE search for randomized, double-blinded, placebo- or active-controlled studies of adult patients treated with antipsychotics for schizophrenia, mania, bipolar depression, or bipolar disorder. We extracted rates of somnolence from original publications and pooled them based on the dose of each antipsychotic in the same psychiatric condition, then estimated the absolute risk increase (ARI) and the number needed to harm (NNH) of an antipsychotic relative to placebo or an active comparator in the same psychiatric condition...
September 2016: CNS Drugs
Richard H Weisler, Ai Ota, Kana Tsuneyoshi, Pamela Perry, Emmanuelle Weiller, Ross A Baker, David V Sheehan
BACKGROUND: Major depressive disorder (MDD) is a common, debilitating disorder with substantial socioeconomic burden. Many patients with MDD experience symptoms that impair functioning and productivity, often negatively affecting work or educational pursuits. This Phase 3b open-label study evaluated adjunctive brexpiprazole in young adults with MDD, who were in work or study. METHODS: Young patients (18-35 years) with MDD (inadequate responders to 1-3 antidepressant treatments [ADT] for their current episode) received brexpiprazole 1-3mg/day (target dose, 2mg/day) adjunctive to the same stable dose of ADT for 12 weeks...
November 1, 2016: Journal of Affective Disorders
Dawn Bruijnzeel, Rajiv Tandon
Antipsychotic agents, utilized for the treatment of a range of psychiatric disorders, differ substantially in terms of their pharmacology and adverse effect profiles. Incomplete and variable efficacy, differences in safety-tolerability, and highly heterogeneous response across individuals prompt development of new agents. Brexpiprazole is one of the two most recently introduced antipsychotic agents approved for the treatment of schizophrenia and as an adjunct for treatment of major depressive disorder. Its pharmacology, clinical trial data, and efficacy and side effects in comparison with other antipsychotic agents are discussed...
2016: Drug Design, Development and Therapy
Ricardo P Garay, Leslie Citrome, George T Grossberg, Icilio Cavero, Pierre-Michel Llorca
INTRODUCTION: Agitation is common and distressing in persons with dementia, but safe, effective treatments remain elusive. In this review, the authors describe investigational compounds in ongoing or recently completed clinical trials for this indication and provide an opinion on how they may meet current therapeutic needs. AREAS COVERED: Phase II and phase III clinical trials for agitation in persons with dementia were searched in US and EU clinical trial registries and in the medical literature for the period January 2013-February 2016 EXPERT OPINION: The authors searches identified 24 recent clinical trials investigating new treatments for agitation in persons with dementia...
August 2016: Expert Opinion on Investigational Drugs
Roger S McIntyre, Emmanuelle Weiller, Peter Zhang, Catherine Weiss
BACKGROUND: Anxiety symptoms are prevalent in major depressive disorder (MDD) and are associated with greater illness severity, suicidality, impaired functioning and poor response to antidepressant treatment (ADT). The efficacy and safety of brexpiprazole - a serotonin-dopamine activity modulator - as adjunctive treatment in patients with MDD was recently evaluated in two phase 3 studies. We here present a post-hoc analysis of the efficacy of adjunctive brexpiprazole in patients with MDD and symptoms of anxious distress, defined using proxies for DSM-5 criteria...
September 1, 2016: Journal of Affective Disorders
Ather Muneer
Bipolar disorder is characterized by exacerbations of opposite mood polarity, ranging from manic to major depressive episodes. In the current nosological system of the Diagnostic and Statistical Manual - 5(th) edition (DSM-5), it is conceptualized as a spectrum disorder consisting of bipolar disorder type I, bipolar disorder type II, cyclothymic disorder, and bipolar disorder not otherwise specified. Treatment of all phases of this disorder is primarily with mood stabilizers, but many patients either show resistance to the conventional mood stabilizing medications or are intolerant to their side-effects...
2016: Curēus
John M Kane, Aleksandar Skuban, Mary Hobart, John Ouyang, Emmanuelle Weiller, Catherine Weiss, Christoph U Correll
Second-generation antipsychotics have demonstrated efficacy for patients with schizophrenia but are associated with wide-ranging side effects. Brexpiprazole, a serotonin-dopamine activity modulator, has demonstrated efficacy in adult patients with schizophrenia. This paper provides an overview of the safety and tolerability of brexpiprazole in patients with schizophrenia through examination of pooled safety data from one Phase 2 and two Phase 3 6-week, short-term studies, and two open-label, 52-week, long-term studies...
July 2016: Schizophrenia Research
Christoph U Correll, Aleksandar Skuban, Mary Hobart, John Ouyang, Emmanuelle Weiller, Catherine Weiss, John M Kane
Brexpiprazole, a serotonin-dopamine activity modulator, is a partial agonist at 5-HT1A and dopamine D2 receptors, and antagonist at 5-HT2A and noradrenaline α1B and α2C receptors, all at similar potency. Efficacy of brexpiprazole was evaluated in patients with acutely exacerbated schizophrenia in three short-term, randomized, double-blind, placebo-controlled studies. In a Phase 2 study, patients were randomized to brexpiprazole 0.25mg (fixed dose), 1.0±0.5mg, 2.5±0.5mg, 5.0±1mg (flexible-dose ranges), placebo, or aripiprazole 15±5mg...
July 2016: Schizophrenia Research
Leslie Citrome
No abstract text is available yet for this article.
May 2016: Evidence-based Mental Health
Karly P Garnock-Jones
Oral brexpiprazole (Rexulti(®)) is a partial dopamine D2 agonist, which also has activity at several other receptors. This article reviews the pharmacological properties of brexpiprazole and its clinical efficacy and tolerability in patients with schizophrenia; its use in patients with major depressive disorder is beyond the scope of this review. Brexpiprazole 2-4 mg/day was generally effective in short-term, phase III studies at improving Positive and Negative Symptom Scale scores and other schizophrenia symptoms in patients with acute schizophrenia...
April 2016: CNS Drugs
Daniel A Hussar, Rebecca Shatynski
No abstract text is available yet for this article.
March 2016: Journal of the American Pharmacists Association: JAPhA
Leslie Citrome, Ai Ota, Kazuhiro Nagamizu, Pamela Perry, Emmanuelle Weiller, Ross A Baker
The aim of this study was to explore the effects of brexpiprazole and aripiprazole on efficacy, cognitive functioning, and safety in patients with acute schizophrenia. Patients who would benefit from hospitalization/continued hospitalization for acute relapse of schizophrenia were enrolled and randomized (2 : 1) to target doses of open-label brexpiprazole 3 mg/day or aripiprazole 15 mg/day for 6 weeks. Outcomes included change from baseline to week 6 in the Positive and Negative Syndrome Scale total score, Barratt Impulsiveness Scale 11-item score, and Cogstate computerized cognitive test battery scores...
July 2016: International Clinical Psychopharmacology
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