Cobenfy: A New Frontier In Schizophrenia Treatment Faces Early Challenges
In September 2024, the U.S. Food and Drug Administration (FDA) approved Cobenfy (xanomeline and trospium chloride), marking the first new class of schizophrenia treatment in over three decades.
Developed by Karuna Therapeutics and acquired by Bristol Myers Squibb for $14 billion in December 2023, Cobenfy offers a novel approach by targeting muscarinic receptors rather than the traditional dopamine pathways.
A Novel Mechanism Of Action
Cobenfy combines xanomeline, a muscarinic receptor agonist, with trospium chloride, a peripherally acting muscarinic antagonist.
This combination aims to stimulate central muscarinic receptors to alleviate schizophrenia symptoms while minimizing peripheral side effects.
Clinical trials demonstrated significant reductions in both positive and negative symptoms of schizophrenia, such as hallucinations and social withdrawal, compared to placebo.
Clinical Trial Outcomes
The FDA’s approval was based on the EMERGENT-2 and EMERGENT-3 Phase 3 trials, which showed that Cobenfy led to statistically significant improvements in schizophrenia symptoms over a five-week period.
Specifically, patients experienced a 9.6-point and 8.4-point greater reduction in the Positive and Negative Syndrome Scale (PANSS) scores in EMERGENT-2 and EMERGENT-3, respectively, compared to placebo.
Setbacks In Adjunctive Therapy Trials
Despite initial successes, Cobenfy faced challenges in a recent Phase 3 trial evaluating its efficacy as an adjunctive treatment for patients with schizophrenia who had an inadequate response to existing antipsychotics.
The study failed to meet its primary endpoint, showing only a two-point improvement over placebo, which was not statistically significant.
This outcome led to a nearly 5% drop in Bristol Myers Squibb’s stock price in after-market trading.
Cobenfy Future Prospects And Ongoing Research
Bristol Myers Squibb remains committed to exploring Cobenfy’s potential in other areas.The company is conducting trials to assess its effectiveness in treating Alzheimer’s-related psychosis, with results expected in 2026.
Additionally, long-term studies are underway to evaluate the drug’s safety and efficacy over extended periods, addressing concerns about its durability and side effect profile.
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