Brexpiprazole: A New Treatment Option for Schizophrenia and Major Depressive Disorder. (April 2017)

• Record Type: Journal Article
• Authors: Markovic, Marija; Gallipani, Alyssa; Patel, Krina H.; Maroney, Megan
• Is Part Of: Annals of pharmacotherapy. Volume 51:Number 4(2017:Apr.)
• Page Start: 315
• Page End: 322
• Publication Date: 2017-04
• Subjects: brexpiprazole -- antipsychotic -- schizophrenia -- major depressive disorder; Chemotherapy -- Periodicals; Pharmacology -- Periodicals; 615.5805
• DOI: 10.1177/1060028016678262
• Languages: English
• ISSNs: 1060-0280

Abstract

Objective: To review the pharmacology and clinical data for brexpiprazole in schizophrenia and major depressive disorder (MDD).Data Sources: An English-language literature search using PubMed and MEDLINE was performed using the term brexpiprazole . All articles containing human clinical trial data published up to September 2016 were evaluated for inclusion as well as information from the manufacturer's product labeling.Study Selection/Data Extraction: Phase 3 trials for brexpiprazole were evaluated. Key in vitro and animal data were incorporated into the pharmacology and pharmacokinetic sections where appropriate.Data Synthesis: Four phase 3 trials have evaluated the use of brexpiprazole as a primary therapy for schizophrenia or as an antidepressant adjunct for MDD. For its schizophrenia indication, brexpiprazole was studied in 2 placebo-controlled trials of approximately 1300 patients, with 4 mg of brexpiprazole consistently showing superiority over placebo. For MDD, brexpiprazole was compared with placebo as an adjunct to antidepressants in approximately 1000 patients who had failed trials of 1 to 3 prior antidepressants. The 2-mg and 3-mg dosages of brexpiprazole showed consistent superiority over placebo in the MDD trials. Common treatment emergent adverse effects included akathisia and weight gain.Conclusions: Brexpiprazole showed efficacy for the treatment of schizophrenia in the range of 2 to 4 mg/d and as an adjunct to antidepressant therapy in MDD when dosed at 2 to 3 mg/d. Advantages of this drug include once-daily dosing, good tolerability, and lack of effect on sexual function. Disadvantages include the lack of long-term safety data and potentially high cost.