The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s first-in-class schizophrenia drug Cobenfy (xanomeline-trospium), providing patients with a new treatment option not seen in decades.
The novel drug – named Cobenfy – introduces a new mechanism of action to the schizophrenia treatment landscape by targeting cholinergic receptors as opposed to dopamine receptors. The market for schizophrenia drugs has long been dominated by dopamine-blocking antipsychotics, which are associated with significant side effects such as Parkinsonian symptoms, sexual dysfunction, and weight gain.
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Originally developed by Karuna Therapeutics and named KarXT, BMS inherited the drug as part of a $14bn acquisition, which was finalised in March 2024. The acquisition is set to pay off as Cobenfy is set to pull in $2.99bn in sales in 2030, according to GlobalData forecasts.
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Cobenfy is a twice-daily pill that combines two drugs: one that targets muscarinic receptors M1 and M4, which increase activity in the parasympathetic nervous system, and another that lessens side effects from activating those receptors. Clinical trial data has shown that the drug relieves symptoms such as delusions without some of the drastic side effects caused by currently approved antipsychotics.
The excitement surrounding Cobenfy also stems from its ability to address both the positive and negative symptoms of schizophrenia. Unlike dopamine receptors, M1 and M4 receptors work on positive symptoms such as hallucinations and delusions, and negative symptoms that include reduced emotional output, speech, and motivation.
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By GlobalDataData from the Phase III EMERGENT-3 trial (NCT04738123) showed that the drug demonstrated an 8.4-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week five. However, the new drug comes with side effects like any other therapy. The prescribing information includes warnings that Cobenfy can cause urinary retention, increased heart rate, decreased gastric movement, or angioedema (swelling beneath the skin) of the face and lips.
In the announcement accompanying the approval, Tiffany Farchione, director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research said: “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Some experts have expressed concerns about the twice-daily dosing schedule of the drug, noting that treatment effectiveness often depends on consistent medication adherence – something that can be difficult for schizophrenia patients, especially given the side effects of traditional antipsychotics. However, in a Q1 2023 earnings call, Karuna’s former CEO Bill Meury suggested that adherence to Cobenfy could surpass standard schizophrenia treatments.
To tackle this issue, Terran Biosciences are developing a prodrug version of xanomeline-trospium, called TerXT. Terran’s candidates keep Cobenfy’s formulation while optimising its dosing schedule to a more convenient once-daily oral regimen, and a multi-month injectable.
BMS said patients can enrol in a patient assistance scheme called the Cobenfy Cares programme in late October when the drug is set to be available.
