FDA Approves Drug for Schizophrenia in Pediatric Patients

Brexpiprazole, known as Rexulti or Rxulti in certain markets, a U.S. Food and Drug Administration (FDA) approved drug for schizophrenia in adults has now been granted approval for use in pediatric patients in the age bracket of 13-17 years, a press release said. The approval for Rexulti’s supplemental new drug application (sNDA) comes after the FDA had previously given the drug a priority review. 

Mechanism of Action

Brexpiprazole was discovered by Otsuka America Pharmaceutical Inc. and is administered as an adjuvant to antidepressants for the treatment of the major depressive disorder (MDD) in adults. Although the exact mechanism of the drug’s action is not fully understood, the drug is effective through its partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors while antagonist activity at the serotonin 5-HT2A receptors. In addition to these, the drug also shows a high affinity to noradrenaline alpha 1B/2C receptors, the press release added. 

The submission for pediatric approval for the drug was based on extrapolation of data conducted on adult participants, analysis of pharmacokinetics of the drug in adult and pediatric trials as well as an open-label long-term trial that has been going on in pediatric patients for six months.  

Trial Data

The ongoing trial includes 194 participants, 140 of which have received the drug for at least six months, and their outcomes were discussed at the Psych Congress recently. The researchers also plan to submit their findings to a peer-reviewed journal later this year. Adverse events seen in pediatric patients were no different from those in adults while safety and effectiveness of the drug for pediatric patients of MDD has not been established yet, the press release said. 

“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, at Lundbeck A/S, who co-develop the drug with Otsuka. 

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, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “We will continue to raise awareness about schizophrenia in adolescents and educate this important community on the availability of effective treatment options.”

“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, chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “We will continue to raise awareness about schizophrenia in adolescents and educate this important community on the availability of effective treatment options.”

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Author

Ameya Paleja