Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia
Inder Kaul, Amy Claxton, Sharon Sawchak, Colin Sauder, Stephen K. Brannan, Edwin Raj, Shiling Ruan, George Konis, David T. Brown, Andrew J. Cutler, Ronald N. Marcus
Abstract
To further characterize the safety and tolerability of oral xanomeline and trospium chloride in the treatment of people with schizophrenia experiencing acute psychosis. ). The pooled safety population comprised 683 participants from the acute trials. Discontinuation rates were similar between groups (xanomeline/ trospium, 27.6%; placebo, 22.7%). Treatment-emergent AEs were reported by 67.9% (xanomeline/trospium) and 51.3% (placebo) of participants, and 51.8% (xanomeline/trospium) and 29.4% (placebo) experienced AEs deemed related to treatment. The most common AEs with xanomeline/trospium were mild or moderate in intensity, transient, and generally gastrointestinal in nature. Subgroups demonstrated clinically nonsignificant differences in incidences of the most common AEs. Rates of EPS, somnolence, and weight gain were low in both groups. In pooled analyses, xanomeline/trospium was generally well tolerated in people with schizophrenia. The most common AEs were mild or moderate in intensity, transient, and consistent with the activity of xanomeline and trospium at muscarinic receptors. Rates of EPS, somnolence, and weight gain were low. ClinicalTrials.gov identifiers: NCT03697252, NCT04659161, NCT04738123.