On September 26, 2024, the U.S. Food and Drug Administration (FDA) approved Cobenfy™ (xanomeline and trospium chloride) capsules for the treatment of adults with schizophrenia. Schizophrenia is a severe chronic mental illness that can cause psychotic symptoms, including delusions, hallucinations and disorganized thoughts. It is also associated with cognitive problems, difficulty with social interaction and lack of motivation. Cobenfy™ is the first oral antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors in the brain. Cobenfy™ contains two ingredients. The first ingredient, xanomeline, treats the symptoms of schizophrenia. The second ingredient, trospium chloride, minimizes the risk of potential side effects from xanomeline.
The approval of Cobenfy™ for the treatment of schizophrenia was based on the results of two clinical studies with identical designs. The effectiveness of Cobenfy™ was evaluated using a rating scale that measures the severity of 30 symptoms of schizophrenia. In both studies, the participants who received Cobenfy™ experienced a meaningful reduction in symptom severity from baseline to week 5 compared to the placebo group. Cobenfy™ should not be prescribed to patients with urinary retention, moderate or severe kidney or liver disease, gastric retention or untreated narrow-angle glaucoma. The most common side effects are nausea, indigestion, constipation, vomiting, elevated blood pressure and heart rate, abdominal pain, diarrhea and dizziness. Cobenfy™ is expected to be available through pharmacies in late October 2024.