FDA Approves Cobenfy for Adults With Schizophrenia

THURSDAY, Nov. 14, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Cobenfy (xanomeline and trospium chloride), a first-in-class muscarinic agonist, for the treatment of schizophrenia in adults.

The oral medication represents the first new class of medicine in several decades and selectively targets M₁ and M₄ receptors in the brain, without blocking D₂ receptors.

The approval is based on the EMERGENT clinical trials. In the phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary end point, showing statistically significant reductions of schizophrenia symptoms versus placebo, as measured by the Positive and Negative Syndrome Scale total score change from baseline to week 5 (9.6-point reduction and 8.4-point reduction in EMERGENT-2 and EMERGENT-3, respectively). In EMERGENT-2, Cobenfy also showed a statistically significant improvement from baseline to week 5 in the Clinical Global Impression-Severity score, a secondary end point. Across both trials, the most common adverse reactions (≥5 percent and at least double versus placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

“Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies,” said Rishi Kakar, M.D., an investigator in the EMERGENT program. “By leveraging a novel pathway, Cobenfy offers a new option to manage this challenging condition.”

Approval of Cobenfy was granted to Bristol Myers Squibb.

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