Xanomeline/trospium chloride in schizophrenia: a profile of its use
摘要
Xanomeline/trospium chloride (COBENFY™) is a promising new treatment option for schizophrenia in the USA. The orally administered, first-in-class drug is composed of xanomeline, an M1 and M4 receptor selective muscarinic agonist, and trospium chloride, a peripherally restricted, non-selective muscarinic antagonist. Across one phase 2 and two phase 3 inpatient studies in adult patients with schizophrenia experiencing acutely exacerbated psychosis, twice-daily treatment with xanomeline/trospium chloride for 5 weeks significantly improved schizophrenia symptoms compared with placebo. Additionally, two long-term, open-label, phase 3 studies demonstrated the efficacy of xanomeline/trospium chloride for up to 52 weeks. Xanomeline/trospium chloride therapy is generally well tolerated. Across the short- and long-term trials, most adverse events were gastrointestinal, of mild or moderate severity, and transient in nature. Xanomeline/trospium chloride treatment was associated with a low risk of extrapyramidal symptoms or metabolic disturbances.