Xanomeline-trospium (Cobenfy<sup>TM</sup>) for Schizophrenia: A Review of the Literature
Colin M. Smith, Morgan Santalucia Augustine, Jessica Dorrough, Steven T. Szabo, Särä Shadaram, Elizabeth A. Hoffman, Andrew J. Muzyk
Abstract
effect for the primary endpoint was around 0.60 in both trials. The medication was well-tolerated in all clinical trials with the most common adverse events being rated as mild-to-moderate. Two long-term, open-label studies with xanomeline-trospium showed that after 52 weeks of treatment more than 75% of participants achieved a > 30% improvement on PANSS total score with a mean decrease in score by 33.3 points. Other improvements were reductions in PANSS positive and negative subscales, PANSS Marder negative factor score, and CGI-S score. In both long-term studies, patients previously in the placebo groups during either phase 2 or phase 3 trials achieved a statistically significant improvement on all efficacy measures starting at week 2. These data suggest that xanomeline-trospium is an effective and well tolerated treatment for schizophrenia with a novel mechanism of action.