The Food and Drug Administration (FDA) yesterday approved Cobenfy (xanomeline and trospium chloride), the first antipsychotic drug approved to treat schizophrenia that does not target dopamine receptors, which has long been the standard of care.
Cobenfy introduces a new approach to treating schizophrenia by selectively targeting muscarinic acetylcholine receptors in the brain; these receptors play a role in cognitive processing.
The FDA’s approval of Cobenfy is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of Cobenfy for up to one year, according to Bristol Myers Squibb, which manufactures the drug.
In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared with placebo, as measured by the Positive and Negative Syndrome Scale total score change from baseline to week five.
According to the FDA, the prescribing information includes warnings that Cobenfy can cause urinary retention, increased heart rate, decreased gastric movement, or swelling of the face and lips. Cobenfy is not recommended for patients with known liver impairment. The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, increased heartbeat, dizziness, and gastroesophageal reflux disease.
“This drug takes the first new approach to schizophrenia treatment in decades,” said Tiffany Farchione, M.D., director of the division of psychiatry, office of neuroscience, in the FDA’s Center for Drug Evaluation and Research. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Cobenfy is expected to be available by late October, at a cost of about $22,500 per year.
For related information, see the Psychiatric News article “Potential Schizophrenia Medications Point to New Disease Model.”
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