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New schizophrenia drug Cobenfy (xanomeline and trospium chloride) receives FDA approval

The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) to treat schizophrenia in adults, offering the first new treatment for the psychiatric disorder in decades.

“This approval provides a new alternative to the antipsychotic medications previously prescribed for people with schizophrenia,” Tiffany Farchione, MD, director of the Division of Psychiatry in the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in the FDA statement.

Cobenfy, formerly called KarXT, is the first in a new family of drugs known as muscarinic agonists, which work by activating two receptors in the brain. Unlike previous antipsychotics that target dopamine receptors in the brain, Cobenfy targets cholinergic receptors, the FDA said in its statement.

“Because KarXT works through a fundamentally different mechanism, it is important that it does not cause the serious side effects seen with previous schizophrenia medications,” says P. Jeffrey Conn, PhD, professor emeritus and founding director of the Warren Center for Neuroscience Drug Discovery at Vanderbilt University School of Medicine in Nashville, Tennessee.

“KarXT does not cause excessive weight gain, metabolic syndrome or motor disorders [involuntary tremors]“Sedation and other side effects commonly seen with previous medications,” says Dr. Conn. “Avoiding these side effects is a major advantage of KarXT.”