The FDA has approved Bristol-Myers Squibb’s highly-ancitipated Cobenfy (xanomeline and trospium chloride), for the treatment of schizophrenia in adults.
The nod marks the first time an antipsychotic targeting cholinergic receptors has been approved, diverging from the traditional approach of targeting dopamine receptors, which has been the standard of care for decades. The drug brings a new pharmacological approach after nearly 30 years of stagnation in treatment barriers.
The approval was based on two clinical studies, both 5-week, double-blind, placebo-controlled trials, which demonstrated significant symptom reduction in patients treated with Cobenfy. The studies used the Positive and Negative Syndrome Scale (PANSS), a widely recognized tool for measuring schizophrenia symptoms. Cobenfy showed meaningful improvements over placebo by the fifth week of treatment.
Cobenfy’s prescribing information includes warnings of potential side effects, such as urinary retention, liver issues, and increased heart rate. It is not recommended for patients with kidney or liver impairments.
Schizophrenia is a severe and chronic mental illness that affects about 1% of the U.S. population and is a leading cause of disability worldwide. Symptoms include hallucinations, cognitive difficulties, and social challenges, and those with the condition are at higher risk of premature death, with nearly 5% dying by suicide.
BMS acquired Cobenfy in a $14 billion deal with Karuna Therapeutics, annnounced in December of 2023. Despite attempts to block the deal, the acquisition was finalized in March of this year.