The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride), for the treatment of schizophrenia, a chronic mental health disorder. Developed by Karuna Therapeutics and now owned by Bristol Myers Squibb, Cobenfy works by targeting cholinergic receptors unlike traditional antipsychotic medications that target dopamine receptors.

This marks a significant departure from the conventional approach to schizophrenia treatment, according to the FDA. Schizophrenia is a debilitating mental illness characterized by hallucinations, delusions, disorganized thinking, and behavioral disturbances. Those affected often struggle to maintain a grasp on reality and may experience cognitive impairments.

Globally, about 24 million people are living with schizophrenia, including 2.8 million in the U.S., where it ranks as one of the top 15 causes of disability. Tragically, the condition is linked to a shortened lifespan, with approximately 5% of patients dying by suicide, the FDA noted.

The approval of Cobenfy is seen as a hopeful development for individuals affected by schizophrenia. “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that profoundly impacts quality of life,” said Tiffany Farchione, Director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research. “This drug offers the first new approach to treating schizophrenia in decades, providing an alternative to previously prescribed antipsychotic medications.”

The effectiveness of Cobenfy was demonstrated in two clinical studies. Over a five-week period, patients’ symptoms were measured using the Positive and Negative Syndrome Scale (PANSS), a 30-item tool used to assess schizophrenia symptoms. Results showed that patients treated with Cobenfy experienced a significant reduction in symptoms compared to those on a placebo.

However, the FDA highlighted several side effects associated with the drug, including nausea, constipation, vomiting, increased heart rate, and diarrhea. Due to the risk of severe side effects, the agency advised against prescribing Cobenfy to patients with urinary retention, kidney, or liver disease.

Earlier this year, in March, Bristol Myers Squibb acquired Karuna Therapeutics for $14 billion, gaining exclusive rights to KarXT (Cobenfy). The company plans to launch the drug by the end of October, with a monthly cost of $1,850, or around $22,500 annually, according to Reuters.

Sales are projected to reach $2.5 billion in the U.S. by 2030. Bristol aims to provide insurance coverage for 80% of patients within the first 12 to 18 months of the drug’s release. To further assist patients, Bristol has introduced a support program called “COBENFY Cares.”