FDA Approves First Schizophrenia Drug with New Treatment Approach in Decades

Photo of a man in destress for illustrative purposes onlyPhoto bywhoismargot | pixabay

The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. This marks a significant advancement, as Cobenfy is the first antipsychotic drug that targets cholinergic receptors rather than the traditional dopamine receptors used in schizophrenia treatment.

“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,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “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.”

Schizophrenia affects about 1% of the U.S. population and can cause psychotic symptoms such as hallucinations, paranoia, and cognitive difficulties. Globally, it ranks as one of the top 15 causes of disability, with patients facing higher risks of early death, and nearly 5% die by suicide.

The effectiveness of Cobenfy was demonstrated in two five-week clinical trials that involved adults diagnosed with schizophrenia. In both studies, participants taking Cobenfy showed a significant reduction in symptoms compared to those given a placebo, as measured by the Positive and Negative Syndrome Scale (PANSS).

While the drug offers hope for patients, it comes with potential risks, including urinary retention, increased heart rate, digestive issues, and angioedema (swelling under the skin). It is not recommended for patients with liver or kidney impairments, and those experiencing symptoms of liver disease should discontinue use. Common side effects include nausea, constipation, dizziness, and abdominal pain.

Cobenfy was developed by Bristol-Myers Squibb Company and adds a much-needed alternative for treating schizophrenia, which has long relied on dopamine-based therapies.

For more information, patients can consult the National Institute of Mental Health or speak with their healthcare provider.

The full FDA release can be found here.