Cobenfy Approved for Schizophrenia

On Sept. 26, 2024, Bristol Myers Squibb’s Cobenfy^™ (xanomeline and trospium chloride) was approved by the U.S. Food and Drug Administration (FDA) to treat adults with schizophrenia. It is the first drug in a new class of medications to treat this serious mental illness. Cobenfy targets cholinergic receptors rather than dopaminergic receptors like currently available antipsychotic medications. It is a single capsule that combines xanomeline, a dual M₁– and M₄-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist. The recommended starting dose is 50mg/20mg orally twice daily for at least two days. The dose can then be increased to 100mg/20mg twice daily for at least five days. The maximum dose in some patients is 125mg/30mg twice daily; however, in geriatric patients, the maximum recommended dose is 100mg/20mg twice daily. The dose in older patients should also be titrated up more slowly. Bristol Myers Squibb plans to launch Cobenfy in late October at a list price of $1,850 per month. Full prescribing information can be found here.

At a Glance

• Brand Drug: Cobenfy^™ (xanomeline and trospium chloride)
• Manufacturer: Bristol Myers Squibb
• Date Approved: Sept. 26, 2024
• Indication: to treat schizophrenia in adults
• Dosage Forms Available: xanomeline/trospium chloride capsules: 50mg/20mg, 100mg/20mg and 125mg/30mg
• Launch Date: late October
• Estimated Annual Cost: $22,200
• Schizophrenia is a chronic and debilitating mental health condition that affects approximately 2.8 million Americans. It can impact how a person thinks, feels and behaves. Psychotic symptoms such as hallucinations and delusions can occur in individuals with schizophrenia. Patients may also have negative symptoms, which include loss of motivation, withdrawal from social life, loss of interest in daily activities and difficulty showing emotions. Cognitive impairment (e.g., difficulty concentrating and memory loss) can also be an issue for these patients.
• In addition to psychosocial therapy, there are several antipsychotic medications available to treat schizophrenia. These can be taken orally or administered by subcutaneous (SC) or intramuscular (IM) injections. Many of these medications are available generically.
• The approval of Cobenfy was based on clinical data that showed it was effective in significantly reducing schizophrenia symptoms compared to placebo.
• The most common adverse events in Cobenfy-treated patients were nausea, upset stomach, constipation, vomiting and high blood pressure.