Brexpiprazole in the treatment of schizophrenia and agitation in Alzheimer’s disease

2020 ◽  
Vol 10 (4) ◽  
pp. 205-217 ◽  
Author(s):  
Lauren Stummer ◽  
Marija Markovic ◽  
Megan Maroney
Keyword(s):  
Daily Living ◽  
Partial Agonist ◽  
Treatment Options ◽  
Unmet Need ◽  
Adjunctive Treatment ◽  
Metabolic Disturbances ◽  
Major Depressive ◽  
The Us ◽  
Us Fda ◽  
The Eu

Schizophrenia is a disabling psychiatric disorder marked by progressive loss of functionality in activities of daily living with each relapse. Antipsychotics, the mainstay of therapy for schizophrenia, treat hallucinations and delusions but may have intolerable side effects, including metabolic disturbances and extrapyramidal symptoms. Brexpiprazole, a second-generation antipsychotic with dopamine partial agonist properties, was approved by the US FDA in 2015 for the treatment of schizophrenia and adjunctive treatment of major depressive disorder and by the EU in 2018 for adults with schizophrenia. Additionally, brexpiprazole has recently been studied for the treatment of agitation in Alzheimer’s dementia, an area of largely unmet need. Overall, well-tolerated brexpiprazole expands the armamentarium of treatment options available for these conditions.

Antidepressants Augmented with Aripiprazole in the Treatment of Major Depressive Disorder

2017 ◽  
Vol 41 (S1) ◽  
pp. S141-S141
Author(s):  
S. Bise ◽  
G. Sulejmanpasic ◽  
D. Begic ◽  
M. Ahmic
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Low Dose ◽  
Adjunctive Treatment ◽  
Major Depressive ◽  
The Us ◽  
Minimal Improvement ◽  
History Of ◽  
The Mean ◽  
Ad Therapy

IntroductionMajor depressive disorder (MDD) does not consistently respond to any single antidepressant (AD) therapy. Adjunctive therapy with atypical antipsychotics (AA) showed higher response rates compared with AD monotherapy. Aripiprazole, an oral quinolinone, is the first AA agent to be approved in the US as adjunctive treatment in adult patients with MDD.Aim The aim was to evaluate the efficacy and safety of adjunctive low-dose aripiprazole combined with AD versus AD monotherapy in patients with MDD with minimal improvement after 4 weeks of prior AD monotherapy.MethodsTen patients with MDD and a history of minimal improvement to 4 weeks of AD monotherapy (escitalopram 10–15 mg/day, sertralin 50–100 mg/day) were included in this study. The patients were randomly assigned to 2 groups: one (n = 5) with AD plus aripiprazole 5–7.5 mg/day and the other (n = 5) with AD alone. After baseline assessment, the subjects were followed up at weeks 2, and 4. The primary efficacy was the mean change in (HAM-D17) and CGI-I.ResultsThe aripiprazole group exhibited significantly better efficacy than the AD group in mean total score changes of HAM-D17 and CGI from the baseline to weeks 2, and 4. The item “work and social activities” of HAM-D 17 showed significant improvement at week 4, and the item “somatic symptoms (GI)” showed significant improvement at week 2.ConclusionsAdjunctive aripiprazole therapy significantly improved depressive symptoms in MDD who didn’t respond to AD monotherapy. Aripiprazole augmentation is an efficacious, well-tolerated and safe treatment for patients with MDD.

scholarly journals The Role of the Gut Microbiota in the Development and Progression of Major Depressive and Bipolar Disorder

Nutrients ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 37
Author(s):  
Tom Knuesel ◽  
M. Hasan Mohajeri
Keyword(s):  
Bipolar Disorder ◽  
Depressive Symptoms ◽  
Gut Microbiota ◽  
Intestinal Microbiota ◽  
Treatment Options ◽  
Twin Studies ◽  
Adjunctive Treatment ◽  
Major Depressive ◽  
Response Parameter ◽  
Health Promoting

A growing number of studies in rodents indicate a connection between the intestinal microbiota and the brain, but comprehensive human data is scarce. Here, we systematically reviewed human studies examining the connection between the intestinal microbiota and major depressive and bipolar disorder. In this review we discuss various changes in bacterial abundance, particularly on low taxonomic levels, in terms of a connection with the pathophysiology of major depressive and bipolar disorder, their use as a diagnostic and treatment response parameter, their health-promoting potential, as well as novel adjunctive treatment options. The diversity of the intestinal microbiota is mostly decreased in depressed subjects. A consistent elevation of phylum Actinobacteria, family Bifidobacteriaceae, and genus Bacteroides, and a reduction of family Ruminococcaceae, genus Faecalibacterium, and genus Roseburia was reported. Probiotics containing Bifidobacterium and/or Lactobacillus spp. seemed to improve depressive symptoms, and novel approaches with different probiotics and synbiotics showed promising results. Comparing twin studies, we report here that already with an elevated risk of developing depression, microbial changes towards a “depression-like” microbiota were found. Overall, these findings highlight the importance of the microbiota and the necessity for a better understanding of its changes contributing to depressive symptoms, potentially leading to new approaches to alleviate depressive symptoms via alterations of the gut microbiota.

scholarly journals Brexpiprazole: A review of a new treatment option for schizophrenia and major depressive disorder

2017 ◽  
Vol 7 (5) ◽  
pp. 207-212 ◽  
Author(s):  
Lauren A. Diefenderfer ◽  
Courtney Iuppa
Keyword(s):  
Clinical Trials ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Partial Agonist ◽  
Adjunctive Treatment ◽  
Inadequate Response ◽  
Major Depressive ◽  
Two Phase ◽  
New Treatment

Abstract Brexpiprazole is an atypical antipsychotic that works as a partial agonist at serotonin 5-hydroxytryptamine1A and dopamine D2 receptors and an antagonist at serotonin 5-hydroxytryptamine2A. It has US Food and Drug Administration approval for monotherapy treatment of schizophrenia and adjunctive treatment to antidepressants for major depressive disorder. Two phase-3 clinical trials demonstrated efficacy and relatively fair tolerability with regard to adverse effects for each indication. Akathisia was frequently reported in the major depressive disorder trials but less so in the schizophrenia trials. Significant increases in body weight and triglycerides were seen across all studies. Brexpiprazole appears to be a viable option for treating an acute exacerbation of schizophrenia requiring hospitalization or adjunctive treatment of major depressive disorder in patients who showed an inadequate response to 1 to 3 antidepressants. Further clinical trials are warranted to determine the long-term efficacy of brexpiprazole, and comparison trials would be beneficial to establish its place in therapy.

scholarly journals Discovery of drugs that possess activity against feline leukemia virus

2012 ◽  
Vol 93 (4) ◽  
pp. 900-905 ◽  
Author(s):  
Willie M. Greggs ◽  
Christine L. Clouser ◽  
Steven E. Patterson ◽  
Louis M. Mansky
Keyword(s):  
Leukemia Virus ◽  
Treatment Options ◽  
Feline Leukemia Virus ◽  
Drug Classes ◽  
The Us ◽  
Us Fda ◽  
Hiv Drugs ◽  
Toxic Concentrations ◽  
Anti Hiv ◽  
Hiv 1

Feline leukemia virus (FeLV) is a gammaretrovirus that is a significant cause of neoplastic-related disorders affecting cats worldwide. Treatment options for FeLV are limited, associated with serious side effects, and can be cost-prohibitive. The development of drugs used to treat a related retrovirus, human immunodeficiency virus type 1 (HIV-1), has been rapid, leading to the approval of five drug classes. Although structural differences affect the susceptibility of gammaretroviruses to anti-HIV drugs, the similarities in mechanism of replication suggest that some anti-HIV-1 drugs may also inhibit FeLV. This study demonstrates the anti-FeLV activity of four drugs approved by the US FDA (Food and Drug Administration) at non-toxic concentrations. Of these, tenofovir and raltegravir are anti-HIV-1 drugs, while decitabine and gemcitabine are approved to treat myelodysplastic syndromes and pancreatic cancer, respectively, but also have anti-HIV-1 activity in cell culture. Our results indicate that these drugs may be useful for FeLV treatment and should be investigated for mechanism of action and suitability for veterinary use.

scholarly journals Clinical evaluation of the oral gonadotropin-releasing hormone-antagonist elagolix for the management of endometriosis-associated pain

2019 ◽  
Vol 9 (5) ◽  
pp. 497-515 ◽  
Author(s):  
Hugh S Taylor ◽  
Erica C Dun ◽  
Kristof Chwalisz
Keyword(s):  
Pelvic Pain ◽  
Treatment Options ◽  
Chronic Inflammatory Disease ◽  
Gonadotropin Releasing Hormone ◽  
The Novel ◽  
Releasing Hormone ◽  
The Us ◽  
Partial Suppression ◽  
Us Fda ◽  
Pain Symptoms

Endometriosis is an estrogen-dependent chronic inflammatory disease associated with pelvic pain symptoms that are often severe, mainly dysmenorrhea, nonmenstrual pelvic pain and dyspareunia. This condition is also associated with peripheral and central sensitization. The current medical treatment options for endometriosis-associated pain are limited. Recently, the US FDA approved the novel, oral, nonpeptide gonadotropin-releasing hormone antagonist elagolix for the management of moderate to severe endometriosis-associated pain. Elagolix produces dose-dependent estrogen suppression, from partial suppression at lower doses to nearly full suppression at higher doses. This review article summarizes the current understanding of the pathophysiology of endometriosis, with a focus on the role of estrogen and the mechanisms of pain symptoms, and reviews the clinical development of elagolix in women with endometriosis-associated pain.

scholarly journals The Need for Faster Insulin

2016 ◽  
Vol 11 (1) ◽  
pp. 157-159 ◽  
Author(s):  
Douglas B. Muchmore
Keyword(s):  
Unmet Need ◽  
The Us ◽  
Treatment Of Diabetes ◽  
Mealtime Insulin ◽  
Us Fda ◽  
Meal Ingestion ◽  
Inhalation Powder ◽  
Made In ◽  
Fast Insulin

Considerable progress in treatment of diabetes has been made in the nearly 100 years following the discovery of insulin, and advances in insulin therapy have improved convenience, quality of life, overall glycemic control (A1C), and risk of hypoglycemia. An unmet need remains for a mealtime insulin that can faithfully reproduce the metabolic profile that ensues following meal ingestion in healthy persons. A number of “ultra-fast” insulin programs have been initiated, and Afrezza® (insulin human; Inhalation Powder, MannKind Corporation, Danbury, CT) stands as the first such product to be approved by the US FDA. Afrezza is unique as an “ultra-ultra” fast insulin, faster than any other entrant except IV insulin. The benefits and limitations of the Afrezza profile are discussed in this analysis.

Current Therapies for Alzheimer’s Disease

2013 ◽  
pp. 844-853
Author(s):  
Mary Sano ◽  
Judith Neugroschl
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Treatment Options ◽  
Synaptic Function ◽  
The Us ◽  
Current Therapies ◽  
Anti Oxidant ◽  
Medical Foods ◽  
Us Fda ◽  
Specific Insulin

Dementia and Alzheimer’s disease effects more than 5million people in the US yet the treatment options are minimal. There are five medications representing 2 classes of drugs that were approved by the US FDA between 1994 and 2003 and they provide modest effect on clinical outcomes. In the past decade medical foods have also become available with a specific indication for Alzheimer’s disease. Though once promising, rigorously conducted clinical trials, have demonstrated the lack of efficacy of several agents including anti-inflammatory and anti-oxidant agents, hormones, agents that modify cardiovascular and metabolic risk and a number of vitamins and nutritional supplements. Enthusiasm remains high for identifying agents to modify brain specific insulin resistance and to improve synaptic function and reduce cell death.

Nerivio® remote electrical neuromodulation for acute treatment of chronic migraine

2021 ◽  
Author(s):  
Hida Nierenburg ◽  
Alit Stark-Inbar
Keyword(s):  
Acute Treatment ◽  
Consensus Statement ◽  
Smartphone Application ◽  
Tier 2 ◽  
Tel Aviv ◽  
Real World Evidence ◽  
The Us ◽  
Us Fda ◽  
Electrical Neuromodulation ◽  
The Eu

Nerivio® (by Theranica Bio-Electronics Ltd, Tel Aviv, Israel) is a wireless, wearable, noninvasive, battery-operated, remote electrical neuromodulation device controlled by a smartphone application. It is US FDA authorized for the acute treatment of migraine with or without aura in people 12 years and older in the US, and European Conformity (CE) marked for the same indication in the EU. The American Headache Society Consensus Statement recommends Nerivio as a tier 2 treatment for migraines. This review summarizes a series of five independent clinical trials and two real-world evidence studies that established safety, tolerability and efficacy of Nerivio in treating migraine attacks. It further provides up-to-date practical information on device usability. Based on findings of this review, Nerivio offers a safe and effective nonpharmacological alternative for acute treatment in patients with chronic (and nonchronic) migraine.

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