The Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Rexulti (brexpiprazole) for the treatment of schizophrenia in adolescents 13 years of age and older. Previously, the treatment was only approved for adults.
The approval is based on data from an ongoing, multicenter, long-term, open-label phase 3 trial (ClinicalTrials.gov Identifier: NCT03238326) evaluating the safety and tolerability of brexpiprazole, an atypical antipsychotic, as maintenance treatment of 194 patients aged 13 to 17 years with schizophrenia, of which 140 received brexpiprazole for at least 6 months.
The safety profile of brexpiprazole in this age group was generally consistent with that observed in adults. The most common adverse event was somnolence.
The Rexulti prescribing information has been updated to reflect the following study data associated with metabolic changes reported in pediatric patients:
- Among patients with normal baseline fasting glucose, 2.7% experienced a shift from normal to high (<100mg/dL to ≥126mg/dL).
- Among patients with normal baseline fasting total cholesterol, 7% experienced a shift from normal to high (<170mg/dL to ≥200mg/dL).
- Among patients with normal baseline high-density lipoprotein cholesterol, 12.9% experienced a shift from normal to low (≥40mg/dL to <40mg/dL).
- Among patients with normal baseline triglycerides, 8.5% experienced shifts from normal to high (<150mg/dL to ≥200mg/dL).
Additionally, pediatric patients treated with Rexulti experienced a mean weight increase from baseline to last visit of 3.8kg. During treatment, pediatric patients should be monitored for weight gain and assessed against that expected for normal growth.
Rexulti is supplied as 0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg strength tablets.
Rexulti. Package insert. Otsuka America Pharmaceutical, Inc; 2021. Accessed December 29, 2021. https://www.otsuka-us.com/sites/g/files/qhldwo4131/files/media/static/Rexulti-PI.pdf.