FDA News: Issue 1-4, January 2022

Author: [AUTHOR] Published on 1/14/2022 5:00:00 AM

FDA Approves REXULTI (Brexpiprazole) for Pediatric Patients 13 to 17 Years of Age for the Treatment of Schizophrenia Utilizing Extrapolation of the Adult Effectiveness Data

On December 27, 2021, the U.S. Food and Drug Administration (FDA) approved an efficacy supplemental new drug application for REXULTI (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age. REXULTI is already approved in adults for the treatment of schizophrenia and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). 

For the treatment of schizophrenia in pediatric patients 13 to 17 years of age, REXULTI should be started at 0.5 mg once daily on Days 1 to 4, taken orally with or without food; then titrated to 1 mg once daily on Day 5 through Day 7, then to 2 mg on Day 8 based on the patient’s clinical response and tolerability. Weekly dose increases can be made in 1 mg increments. The recommended target REXULTI dosage is 2 mg to 4 mg once daily. The maximum recommended daily dosage is 4 mg.

Effectiveness of brexpiprazole in the treatment of schizophrenia in pediatric patients aged 13 years and older was extrapolated from adult data, based on comparable systemic exposure of brexpiprazole in pediatric patients 13 to 17 years of age and adult patients in the therapeutic dose range. In addition to the multiple dose pharmacokinetic (PK) study in pediatric patients 13 to 17 years of age, population PK analysis indicated systemic exposure (Cmax and AUC) of brexpiprazole in pediatric patients 13 to 17 years of age was comparable to that in adult patients across the dose range from 0.5 to 4 mg.

On January 13, 2020, the Division of Psychiatry issued a “General Advice Letter”1 which permits extrapolation of the effectiveness of atypical antipsychotic drugs approved for the treatment of schizophrenia in adults to pediatric patients 13 years of age or older, when clearly laid-out requirements are satisfied. This supplemental application is the first approval of a pediatric efficacy application of an atypical antipsychotic drug for schizophrenia that relies on this extrapolation approach.

Additional information regarding the adult indications, approved recommended dosage and administration, drug interactions, common adverse reactions, as well as warnings and precautions about increased mortality in elderly patients with dementia-related psychosis, suicidal thoughts and behaviors in children, adolescents, and young adults, cerebrovascular adverse reactions including stroke in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, pathological gambling and other compulsive behaviors, leukopenia, neutropenia, and agranulocytosis, orthostatic hypotension and syncope, falls, seizures, body temperature dysregulation, dysphagia, and potential for cognitive and motor impairment can be found in the full prescribing information linked below.


1 Kalaria SN, Farchione TR, Uppoor R, Mehta M, Wang Y, Zhu H. Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder. J Clin Pharmacol. 2021 Jun;61 Suppl 1:S117-S124. doi: 10.1002/jcph.1836. PMID: 34185904.

Full prescribing information is available at https://go.usa.gov/xtCTv.

Visit Drugs@FDA at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval. 

A non-comprehensive list of examples of clinical substrates, inhibitors and inducers for metabolic and transporter system related interactions may be found at https://go.usa.gov/xXY9C.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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