FDA Approves First-in-Class Schizophrenia Drug: Daily Dose

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On September 27, 2024, we reported on the US Food and Drug Administration (FDA) approval of Cobenfy, formerly known as KarXT (xanomeline-trospium; BMS), a first-in-class agent for the treatment of schizophrenia.

The approval

Cobenfy is the first new agent with a novel mechanism of action for schizophrenia more than 50 years.

The decision was based on data from the EMERGENT trials, which looked at safety and efficacy data across multiple studies. The most recent, EMERGENT-4 and EMERGENT-5 were phase 3 open label trials, looking at 718 participants who received at least 1 dose and 134 participants who completed a year of treatment over 52 weeks. The data indicated the drug was generally well tolerated, with no significant changes in prolactin and movement disorder scale scores and stabilization or improvement in key metabolic parameters, including weight and total cholesterol, triglyceride and HbA1c levels. About 65% of participants saw a decrease in weight; the mean decrease in weight over a year was 2.6 kg. The most common treatment-related adverse events were mild or moderate and transient in nature, and included gastrointestinal issues (ie, nausea, vomiting, dyspepsia, constipation, diarrhea), dry mouth, dizziness, and hypertension.

Click here for more details.