Bristol-Myers Squibb has announced the latest topline results from its Phase 3 open-label trials, EMERGENT-4 and EMERGENT-5, for the drug Cobenfy (a combination of xanomeline and trospium chloride). The analysis indicates that adult patients with schizophrenia continue to show improved symptoms after 52 weeks of treatment, demonstrating sustained efficacy.
Earlier this year, Cobenfy was recognized by industry media as one of the top ten potential blockbuster therapies likely to be approved in 2024. The drug consists of two active ingredients, xanomeline and trospium chloride, designed to activate muscarinic acetylcholine receptors in the brain while minimizing effects on peripheral receptors.
Xanomeline aids in alleviating negative symptoms such as apathy and reduced social motivation, enhancing cognitive functions, and improving other psychiatric symptoms like hallucinations and delusions by stimulating the M1 and M4 muscarinic receptors. Trospium chloride, a quaternary ammonium compound, serves as a muscarinic receptor antagonist to mitigate peripheral side effects of xanomeline.
The U.S. FDA approved Cobenfy capsules in September for treating adult patients with schizophrenia. This marks the first antipsychotic drug targeting cholinergic receptors, a departure from the traditional dopamine receptor-focused treatments for schizophrenia, and introduces a novel mechanism for treatment after several decades.
