Applying EMERGENT Trial Results to Real-World Clinical Practice for Schizophrenia

In this segment of our HCPLive Special Report on the recent approval of xanomeline and tropism chloride capsules (Cobenfy) for schizophrenia, leading subject matter experts discuss their interpretation of clinical trial data from the pivotal EMERGENT trials and their impact on schizophrenia treatment.

The US Food and Drug Administration (FDA) approved xanomeline and trospium chloride capsules, formerly KarXT, for the treatment of schizophrenia. The decision followed 2 critical phases of the trials: the 5-week acute studies focusing on symptom reduction and the open-label studies assessing safety and sustained efficacy over 52 weeks. The trials measured symptom improvement using the Positive and Negative Syndrome Scale (PANSS), which showed a significant difference between the treatment and placebo groups.

A principal investigator of the EMERGENT trials, Rishi Kakar, MD, noted that 75% of patients maintained their improvements by the end of the 52-week trial period. Although acknowledging that the drug may not be suitable for all patients, Kakar said the trials reveal a fundamental new approach to schizophrenia treatment. Andrew J. Cutler joined in to underline the significance of these findings and their current implications, particularly for patients who may not respond fully to current antipsychotic therapies.

Series Segments:

• Introductions
• Mechanism of Action of Xanomeline and Trospium Chloride Capsules
• Applying EMERGENT Trial Results to Real-World Clinical Practice for Schizophrenia
• Balancing the Benefits and Risks of Xanomeline and Trospium Chloride Capsules
• Unmet Needs, Future Research in Schizophrenia and Muscarinic Agonists

Subject Matter Experts

• Sam Clark, MD, PhD, (Moderator) is a former practicing psychiatrist and is the founder and chief executive officer of Terran Biosciences.
• Andrew Cutler, MD, is a clinical associate professor in the Department of Psychiatry and Behavioral Sciences at SUNY Upstate Medical University and the chief medical officer of the Neuroscience Education Institute.
• Rishi Kakar, MD, is a psychiatrist based out of southern Florida as well as the medical director and chief scientific officer of Segal Trials. Kakar served as the principal investigator on the pivotal EMERGENT trials.

Relevant disclosures for Cutler include Karuna, Bristol Myers Squibb, and others. Relevant disclosures for Kakar include Karuna, Bristol Myers Squibb, and others. Relevant disclosures for Clark include Terran Biosciences.