Neurobehavioral Disorders

Cobenfy Approved for Adult Patients with Schizophrenia

Jaymin Kang, PharmD
|
Publish Date
Data from the EMERGENT trials showed statistically significant reductions in schizophrenia symptom severity compared with placebo.

The Food and Drug Administration (FDA) has approved Cobenfy® (xanomeline and trospium chloride) for the treatment of adults with schizophrenia.

Cobenfy® is a first-in-class, twice-daily, oral medication that contains xanomeline, a selective M1 and M4 muscarinic receptor agonist, and trospium chloride, a muscarinic receptor antagonist that works primarily in the tissues peripherally. 

Approval was based on data from the phase 3 placebo-controlled EMERGENT-2 (ClinicalTrials.gov Identifier: NCT04659161) and EMERGENT-3 trials (ClinicalTrials.gov Identifier: NCT04738123) which had identical designs. 

Study participants (N=470) were randomly assigned to receive xanomeline and trospium chloride 50mg/20mg twice daily for 2 days, followed by 100 mg/20mg twice daily for days 3 to 7 days, and then 125 mg/30mg twice daily or placebo for 5 weeks.

The primary endpoint was met by the treatment groups in both trials showing statistically significant reductions from baseline to week 5 in the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo:

  • In the EMERGENT-2 trial there was a 9.6 point reduction (-21.2 xanomeline and trospium chloride vs -11.6 placebo; P <.0001); and
  • In the EMERGENT-3 trial there was an 8.4 point reduction (-20.6 xanomeline and trospium chloride vs -12.2 placebo; P <.0001).

In the EMERGENT-2 trial, the secondary endpoint, change from baseline Clinical Global Impression-Severity (CGI-S) score at week 5, also significantly improved in the xanomeline and trospium chloride group compared with placebo (-1.2 xanomeline and trospium chloride vs -0.7 placebo; P <.0001)

The most common adverse reactions (at least 5% and twice placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

Gordon Lavigne, chief executive officer of the Schizophrenia & Psychosis Action Alliance, said, “People living with schizophrenia want and deserve more. Today’s approval provides a new option as people with schizophrenia move forward with proper support to rebuild their lives.”

Cobenfy® is supplied in 50 mg/20mg, 100 mg/20mg, and 125 mg/30mg capsule strengths of xanomeline and trospium chloride.

This article originally appeared on MPR

References:
  1. US Food and Drug Administration Approves Bristol Myers Squibb’s CobenfyTM  (xanomeline and trospium chloride), a first-in-class muscarinic agonist for the treatment of schizophrenia in adults. News release. Bristol Myers Squibb. September 27, 2024. https://www.businesswire.com/news/home/20240925382351/en/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibb%E2%80%99s-COBENFY%E2%84%A2-xanomeline-and-trospium-chloride-a-First-In-Class-Muscarinic-Agonist-for-the-Treatment-of-Schizophrenia-in-Adults.
  2. 2. Cobenfy. Package insert. Bristol Myers Squibb; 2024. Accessed September 27, 2024. https://packageinserts.bms.com/pi/pi_cobenfy.pdf.