FDA Approves Cobenfy for Adults With Schizophrenia
By Lori Solomon HealthDay Reporter
THURSDAY, Nov. 14, 2024 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted November 2024
Read this next
Antipsychotics at Doses >75 mg a Day Linked to Risk for Tardive Dyskinesia
FRIDAY, Jan. 17, 2025 -- Antipsychotics at doses >75 mg/day are associated with an increased risk for tardive dyskinesia (TD), according to a study recently published in the...
Pandemic Led to Rapid Adoption of Telemental Health for Those With Schizophrenia
FRIDAY, Jan. 17, 2025 -- For Medicaid beneficiaries with schizophrenia, delivery of mental health care through telehealth (telemental health care) diffused rapidly after onset of...
Guidance Issued for Use of Metformin to Prevent Antipsychotic-Induced Weight Gain
MONDAY, Dec. 30, 2024 -- In a guideline published online Dec. 9 in Schizophrenia Bulletin, recommendations are presented for the use of metformin to prevent antipsychotic-induced...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.