FDA approves first new schizophrenia drug in decades

The U.S. Food and Drug Administration has approved Cobenfy capsules for oral use to treat schizophrenia in adults. It is the first new drug in decades to help people with mental illness.

A press release states that Cobenfy “is the first antipsychotic approved for the treatment of schizophrenia that targets cholinergic receptors, as opposed to dopamine receptors, which have long been the standard of care,” Tiffany Farchione, MD, director of the Division of Psychiatry , Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, shared her thoughts on how the drug can help people with mental illnesses.

“Schizophrenia is one of the most common causes of disability worldwide. It is a serious, chronic mental illness that often affects a person’s quality of life,” she said. “This drug is the first new approach to treating schizophrenia in decades. This approval offers a new alternative to the antipsychotics previously prescribed to people with schizophrenia.”

Those suffering from this disease may experience symptoms such as hallucinations, difficulty controlling their thoughts, and distrust of others. Schizophrenia can also be associated with cognitive problems.

About 1% of Americans suffer from this disease. Additionally, it is one of the leading causes of disability worldwide. The press release indicates that people with schizophrenia are at risk of dying earlier and that a small percentage die by suicide.

How does Cobenfry help people with schizophrenia?

It is the first antipsychotic approved to treat schizophrenia that targets cholinergic receptors rather than dopamine receptors, which have long been the standard treatment.

– US FDA (@US_FDA) September 26, 2024

“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 FDA press release said.

Bristol Myers Squibb makes the drug, Reuters reports. The company obtained the drug, known as KarXT, through its $14 billion acquisition of Karuna Therapeutics in 2023.

Common side effects of the drug include nausea, indigestion, constipation, vomiting, high blood pressure, abdominal pain, diarrhea, tachycardia (increased heart rate), dizziness, and gastroesophageal reflux disease.