FDA approves drug with new mechanism of action to treat schizophrenia

SILVER SPRING, Md., September 26, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use to treat schizophrenia in adults. It is the first antipsychotic approved to treat schizophrenia that targets cholinergic receptors rather than dopamine receptors, which have long been the standard treatment.

“Schizophrenia is a leading cause of disability worldwide. It is a serious, chronic mental illness that often affects a person’s quality of life.” said Tiffany FarchioneMD, Director of the Division of Psychiatry, Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. “This drug represents the first new approach to treating schizophrenia in decades. This approval provides a new alternative to the antipsychotics previously prescribed to people with schizophrenia.”

Schizophrenia can cause psychotic symptoms such as hallucinations (e.g. hearing voices), difficulty controlling thoughts, and distrust of others. It can also be associated with cognitive problems and difficulties with social interactions and motivation. Approximately 1% of Americans suffer from the disease and it is one of the top 15 causes of disability worldwide. People with schizophrenia have a higher risk of dying at a younger age, and nearly 5% die by suicide.

The effectiveness of Cobenfy in treating schizophrenia in adults was examined in two studies with identical designs. Study 1 and Study 2 were 5-week, randomized, double-blind, placebo-controlled, multicenter studies in adults diagnosed with schizophrenia according to DSM-5 criteria.

The primary efficacy measure was change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week 5. The PANSS is a 30-item scale that measures symptoms of schizophrenia. Each point is rated by a doctor on a seven-point scale. In both studies, participants who received Cobenfy experienced a significant reduction in symptoms from baseline to Week 5, as measured by the PANSS total score, compared to the placebo group.

The prescribing information contains warnings that Cobenfy may cause urinary retention, increased heart rate, decreased stomach movement, or angioedema (swelling under the skin) of the face and lips. Cobenfy is not recommended for patients with mild liver impairment. It should not be used in patients with known liver impairment. There is also a risk of liver damage. Patients should stop using Cobenfy if they notice any signs or symptoms of significant liver disease (including yellowing of the skin or the whites of the eyes, dark urine, and unexplained itching). Cobenfy is largely eliminated by the kidneys and is not recommended in patients with moderate to severe renal impairment.

Cobenfy should not be prescribed to patients with urinary retention, moderate or severe kidney or liver disease, gastric retention, untreated angle-closure glaucoma, or known hypersensitivity to Cobenfy or its components.

The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, high blood pressure, abdominal pain, diarrhea, tachycardia (increased heart rate), dizziness, and gastroesophageal reflux disease.

Cobenfy's approval was granted to Bristol-Myers Squibb Company.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our nation's food supply, cosmetics, dietary supplements, and radiation-emitting electronic products, as well as for regulating tobacco products.

SOURCE US Food and Drug Administration