For U.S. Healthcare Professionals only.

For U.S. Healthcare Professionals only.

Indication

EMERGENT trial designs

The COBENFY clinical trial program evaluated more than 1250 patients1

Three 5-week studies* evaluated mean change in PANSS total score in adult patients with schizophrenia experiencing acute psychosis.2

EMERGENT-2 & -3 were phase 3 trials, and EMERGENT-1 was a phase 2 trial.1

EMERGENT trial design

Primary end point2:

  • Change in PANSS total score from baseline at Week 5 

Prespecified secondary end points5-7:

  • Change from baseline at Week 5 in PANSS positive subscale score, PANSS negative subscale score, PANSS Marder negative factor score, and CGI-S score 
  • Proportion of participants with at least a 30% reduction from baseline to Week 5 in PANSS total score (EMERGENT-2 & -3 only)
* Pivotal 5-week trials were placebo controlled.4,7
Markedly ill=symptoms that impair social or occupational function or cause intrusive levels of distress.8
Day 34 for EMERGENT-1.1
§ Safety follow-up only occurred in 2 out of the 3 clinical trials.1

Two 52-week, open-label studies evaluated long-term safety and efficacy1

 EMERGENT-4 and EMERGENT-5 trial design
  • Two long-term, 52-week, phase 3, open-label studies1
  • EMERGENT-4 included patients who previously completed the treatment period of EMERGENT-2 or EMERGENT-31
  • EMERGENT-5 included a patient population with the following select characteristics1:
    • Aged 18 to 65 years at time of screening
    • No psychiatric hospitalization, acute crisis intervention, or other inpatient care within 8 weeks prior to screening
    • PANSS score of ≤80
    • CGI-S score of ≤4
    • Received an oral antipsychotic medication within 30 days prior to screening
    • Antipsychotic down-taper, if clinically appropriate in the opinion of the investigator, may occur during the screening phase
  • The primary objective of these studies was to assess the long-term safety and tolerability of COBENFY1
  • The secondary objective was to assess the long-term efficacy and evaluate plasma concentrations of xanomeline and trospium chloride after administration of COBENFY1

BID=twice daily; CGI-S=Clinical Global Impression - Severity Scale; PANSS=Positive and Negative Syndrome Scale.

View the PANSS total score data in phase 3 trials

References: 

  1. Data on file. Karuna Therapeutics, Inc., a Bristol Myers Squibb Company; Boston, MA.
  2. Kaul I, Citrome L, Sawchak S, et al. Efficacy of KarXT (xanomeline–trospium) in schizophrenia: 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.
  3. Mortimer A. Symptom rating scales and outcome in schizophrenia. Br J Psychiatry. 2007;191(suppl50):s7-s14.
  4. COBENFY. Prescribing Information. Bristol Myers Squibb Company; 2024.
  5. 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.
  6. 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.
  7. 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.
  8. Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007;4(7):28-37.


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