Abigail Shimniok

The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride, or KarXT) on Sept. 26. Cobenfy is a capsule intended to be taken orally to treat schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors and not dopamine receptors, which has long been the standard of care when treating schizophrenia.
Schizophrenia can cause symptoms including hallucinations, difficulty controlling one’s thoughts and difficulty remembering or learning new things. It can also be associated with cognitive problems and difficulty with social interactions as well as motivation. Approximately 1% of Americans have schizophrenia, and globally, it is one of the 15 leading causes of disability. Individuals with schizophrenia are at greater risk of dying at a younger age, and nearly 5% die by suicide.
Cobenfy works by selectively targeting the M1 and M4 receptors without blocking the D2 receptor. In testing, patients who used Cobenfy had fewer extrapyramidal symptoms, metabolic adverse effects and sedation when compared to other antipsychotic medications that are currently on the market.
John H. Krystal, MD, a professor of Translational Research, Psychiatry, Neuroscience and Psychology at Yale university, spoke about how Cobenfy is the first schizophrenia drug with a new mechanism of action since the 1950s.
“I think we have a lot to learn about Cobenfy and other medications in this class,” said Krystal. “But having an alternative to D2 receptor blockade as a treatment strategy is really extremely exciting.”
Krystal hopes Cobenfy will be available in the upcoming year.
The approval of Cobenfy was granted to Bristol-Myers Squibb Company.
“People living with schizophrenia have all been essentially treated with a single class of medication for as long as they have been suffering from the disease. Now, here’s a different option,” said Ken Kramer, who works in medical affairs at Karuna Therapeutics, a subsidiary of BMS. “That’s where the greatest level of excitement is from.”
BMS is also testing KarXT in psychosis associated with diseases other than schizophrenia, such as Alzheimer’s disease.