Rxulti(brexpiprazole)

Rxulti (brexpiprazole) is indicated for the treatment of schizophrenia in adults and, following a Type II variation submission on 26 June 2024, for adolescents aged 13 years and older. The FDA approved brexpiprazole for schizophrenia and adjunctive MDD in adults in 2015, for schizophrenia in adolescents in 2021, and for agitation associated with dementia due to Alzheimer’s disease in 2023. EU approval for schizophrenia in adults was granted in 2018.

Efficacy in schizophrenia was demonstrated by changes from baseline in PANSS Total Score compared to placebo at Week 6, with observed LS mean differences of -5.33 and -6.53. In a subgroup of patients aged ≥ 15 years, the PANSS Total Score change from baseline versus placebo at Week 6 was -8.05. The efficacious dose range for adults and the proposed efficacious dose range for adolescents is 2 to 4 mg. Discontinuation due to lack of efficacy in long-term open-label trials was 2.2%.

Safety findings from short-term controlled trials include an incidence of nausea of 5.9% (compared to 4.3% for placebo), akathisia of 4.2% (compared to 2.6% for placebo), and headache of 5.9% (compared to 4.3% for placebo). Treatment-emergent suicidal ideation was reported in 15 subjects, and 9 subjects discontinued due to adverse events. There were no deaths reported.