FDA Approves Schizophrenia Drug for Patients Aged 13-17 Years

Brexipiprazole has been previously approved for adults with schizophrenia and adults with major depressive disorder.

The US Food and Drug Administration (FDA) has approved brexipiprazole (REXULTI) for the treatment of schizophrenia for patients aged 13-17 years.

The treatment, developed by Otsuka America Pharmaceutical, was previously granted Priority Review for the supplemental New Drug Application (sNDA). The drug was also approved in 2015 for adults with schizophrenia, as well as an adjunctive treatment for adults with major depressive disorder (MDD).

The Approval

The approval was based on the data from prior studies of adult patients, pharmacokinetic results from adult and pediatric studies, and the 6 month data from an ongoing open-label, long-term trial among adolescent patients with schizophrenia. The latter study included 194 adolescent patients, 140 of which were treated with brexipiprazole for at least 6 months.


The adverse events for this age group were similar to what was found in the adult studies.

While the mechanism of action of brexipiprazole is not yet fully understood, the efficacy may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

“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, R&D, Lundbeck, in a statement.