FDA Approves the First New Schizophrenia Drug in Decades

The U.S. Food and Drug Administration has approved Cobenfy capsules for oral use in the treatment of schizophrenia in adults. It is the first new drug introduced in decades to help those who have the mental condition.

A press release reveals that Cobenfy “is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.” Tiffany Farchione, M.D., 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 those with mental illness.

“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” she said. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”

Those who have this illness can experience symptoms such as hallucinations, difficulty controlling one’s thoughts, and feeling suspicious of others. Schizophrenia can also be associated with cognitive problems.

About 1% of Americans have this illness. Additionally, it is one of the leading causes of disability across the globe. The press release reveals that those who have schizophrenia are at risk of dying younger, and a small percentage die by suicide.

How Does Cobenfry Help Those Who Have Schizophrenia?

It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.

— U.S. FDA (@US_FDA) September 26, 2024

“Participants who received Cobenfy experienced a meaningful reduction in symptoms from baseline to Week 5 as measured by the PANSS Total Score compared to the placebo group,” said the FDA press release.

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

Common side effects of the drug include nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness, and gastroesophageal reflux disease.