“A Viable Option” for Treating Schizophrenia Receives FDA Approval


The supplemental new drug application of brexpiprazole for the treatment of schizophrenia in pediatric patients aged 13 to 17 received FDA approval.



The US Food and Drug Administration (FDA) has approved Otsuka and Lundbeck’s supplemental new drug application (sNDA) of brexpiprazole for the treatment of schizophrenia in pediatric patients aged 13 to 17.1

The FDA previously granted Priority Review for the sNDA. In 2015, brexpiprazole was approved in the US for the treatment of schizophrenia in adults and for adjunctive treatment of major depressive disorder.

“This approval further bolsters the mental health community’s efforts and resources to address a critical unmet need within the pediatric schizophrenia population,” said Robert McQuade, PhD, president of the McQuade Center for Strategic Research and Development, and chief strategic officer at Otsuka Pharmaceutical Development & Commercialization. “We will continue to raise awareness about schizophrenia in adolescents and educate this important community on the availability of effective treatment options.”

The mechanism of action for brexpiprazole is not fully understood; however, studies of brexpiprazole’s efficacy observed partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors—for which, brexpiprazole exhibits high affinity.

“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,” wrote Lauren A. Diefenderfer, PharmD, BCPP, and Courtney Iuppa, PharmD, BCPP, back in 2017.2

The sNDA submission was based on an extrapolation analysis utilizing data from 3 groups of prior research: 1) studies among adult patients, 2) pharmacokinetic results from adult and pediatric trials, and 3) 6-month data from the ongoing open-label, long-term trial among adolescent patients with schizophrenia.

“We are proud to offer a treatment option for adolescents with schizophrenia who are navigating the complexities of their health during a transitional time in their lives – we hope this will help make a meaningful difference in reducing their schizophrenia symptoms so they can be their best,” said Johan Luthman, executive vice president of research and development at Lundbeck.


1. Otsuka and Lundbeck announce FDA approval of supplemental new drug application for REXULTI® (brexpiprazole) to treat schizophrenia in pediatric patients ages 13-17. News release. BioSpace. January 6, 2022. https://www.biospace.com/article/releases/otsuka-and-lundbeck-announce-fda-approval-of-supplemental-new-drug-application-for-rexulti-brexpiprazole-to-treat-schizophrenia-in-pediatric-patients-ages-13-17/

2. Diefenderfer LA, Iuppa C. Brexpiprazole: a review of a new treatment option for schizophrenia and major depressive disorder. Ment Health Clin. 2017;7(5):207-212.

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