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Indication

Demonstrated safety and tolerability profile for COBENFY1-3

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No Boxed Warning4

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No warnings or precautions for metabolic changes, including weight gain4

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No warning or precaution for tardive dyskinesia4

COBENFY has warnings and precautions for5:

  • Risk of urinary retention
  • Risk of use in patients with
    hepatic impairment
  • Risk of use in patients with biliary disease
  • Decreased gastrointestinal motility
  • Risk of angioedema
  • Risk of use in patients with narrow-angle glaucoma
  • Increases in heart rate
  • Anticholinergic adverse reactions in patients with renal impairment
  • Central nervous system effects

 

Adverse Reactions Reported in ≥2% of COBENFY-Treated Patients and Greater Than Rate of Placebo in EMERGENT-2 & -34

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aDyspepsia includes dyspepsia and esophageal discomfort.4
bHypertension includes hypertension, blood pressure increased, labile hypertension, and orthostatic hypertension.4
cAbdominal pain includes abdominal discomfort, abdominal pain upper, abdominal pain, abdominal pain lower, and abdominal tenderness.4
dTachycardia includes tachycardia, heart rate increased, and sinus tachycardia.4
eCough includes cough and productive cough.4
fEPS (non-akathisia) includes dyskinesia, drooling, dystonia, extrapyramidal disorder, muscle contraction involuntary, and muscle spasms.4

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Overall discontinuation rates due to adverse reactions were similar between COBENFY (6%) and placebo (4%).4

Nausea and vomiting mostly were transient with initial onset in the first couple of weeks of treatment5

Antiemetics were allowed across clinical trials. 4% of patients in those trials used antiemetics (mostly ondansetron).5

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All of these adverse events were categorized as mild to moderate in clinical trials.6*†

*A mild adverse reaction was defined as an event that is easily tolerated by the patient, causing minimal discomfort, and not interfering with everyday activities; a moderate adverse reaction was
defined as an event that was sufficiently discomforting to interfere with—but not prevent—normal everyday activities.5
In clinical trials, 13.9% and 5.2% of patients treated with COBENFY had mild or moderate nausea, respectively, and 10.4% and 4.8% had mild or moderate vomiting, respectively. No patients had severe nausea or vomiting.5

View study design

The safety and efficacy of COBENFY were assessed in 3, randomized, double-blind, placebo-controlled studies. EMERGENT-2 (N=252) and EMERGENT-3 (N=256) were phase 3 trials and EMERGENT-1 (N=182) was a phase 2 trial. The primary end point was change in PANSS total score from baseline at Week 5.5,6 See additional study design details.

See 52-week safety data for COBENFY in adults with schizophrenia

References: 

  1. Brannan SK, Sawchak S, Miller AC, Lieberman JA, Paul SM, Breier A. Muscarinic cholinergic receptor agonist and peripheral antagonist for schizophrenia. N Engl J Med. 2021;384(8):717-726.
  2. Kaul I, Sawchak S, Correll CU, et al. Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial. Lancet. 2024;403(10422):160-170.
  3. Kaul I, Sawchak S, Walling DP, et al. Efficacy and safety of xanomeline-trospium chloride in schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2024;81(8):749-756.
  4. COBENFY. Prescribing Information. Bristol Myers Squibb Company; 2024.
  5. Data on file. Karuna Therapeutics, Inc., a Bristol Myers Squibb company; Boston, MA.
  6. Brannan SK, Cutler AJ, Sawchak S, et al. Safety and tolerability of KarXT (xanomeline–trospium): pooled results from the randomized, double-blind, placebo-controlled EMERGENT trials. Poster presented at: Neuroscience Education Institute Congress; November 9-12, 2023; Colorado Springs, CO.


Cobenfy, Cobenfy Cares, and the Cobenfy logo are trademarks of Karuna Therapeutics, Inc., a Bristol Myers Squibb company.
© 2024 Bristol-Myers Squibb Company. 1629-US-2400140 10/24