FDA approves first-in-class drug for schizophrenia

The US Food and Drug Administration has approved Cobenfy, also known as KarXT, a new schizophrenia treatment . The drug was developed by Karuna Therapeutics, which was bought by Bristol Myers Squibb last year for $14 billion . This is the first new class of treatment for the psychiatric disorder since clozapine, the first atypical antipsychotic , was approved in 1989 . Cobenfy is a combination of xanomeline and trospium. Xanomeline is a muscarinic agonist that engages regulatory pathways in the brain to lower dopamine levels, which is thought to alleviate schizophrenia symptoms. The FDA approved Cobenfy based on the strength of two Phase 3 clinical trials that showed Cobenfy was effective in controlling schizophrenia indicators including hallucinations and depression-like symptoms compared with a placebo ( Lancet 2023, DOI 10.1016/S0140-6736(23)02190-6 ; JAMA Psychiatry 2024, DOI 10.1001/jamapsychiatry.2024.0785 ). But Cobenfy has not been directly compared with already-available antipsychotics. In the 1990s,