‘Really revolutionary’
Following the oral presentation of the study by coauthor Stephen K. Brannan, MD, chief medical officer, Karuna Therapeutics, Boston, the results were warmly received.
Session cochair Mark Weiser, MD, chairman at the department of psychiatry, Sackler School of Medicine, Tel Aviv University, Israel, said the agent is “really revolutionary in the field.
“It’s a non-dopamine compound which helps for schizophrenia, so we’re all very optimistic about it,” Dr. Weiser added.
Nevertheless, he asked Dr. Brannan whether the occurrence of gastrointestinal adverse effects with xanomeline-trospium led to “functional unblinding of the study.”
Dr. Brannan answered that the investigators were “really worried about this prior to EMERGENT-1” but that formal testing suggested it was not a problem.
Dr. Brannan said that although this has not yet been formally tested for the current trial, he believes that it is “highly unlikely” that functional unblinding occurred, inasmuch as the “percentages are about in the same range as we saw in EMERGENT-1.”
Speaking to ECNP Congress Daily in a conference roundup video, session cochair Andreas Reif, MD, PhD, professor of psychiatry, psychosomatic medicine, and psychotherapy at the University Hospital of Frankfurt (Germany), also highlighted the study.
He said that along with a study of dexmedetomidine sublingual film for agitation associated with schizophrenia or bipolar disorder that was also presented in the session, the current trial is “pivotal.”
Dr. Reif noted that the effect size shown with xanomeline-trospium was “really amazing.”
“We are in a really exciting time in treating mental disorders,” he said. “Industry is finally investing again, and really has new compounds that will make it to the market.”
Karuna plans to submit a new drug application with the Food and Drug Administration for KarXT in mid-2023. The drug is also in development for the treatment of psychiatric and neurologic conditions other than schizophrenia, including Alzheimer’s disease.
The study was funded by Karuna Therapeutics. Dr. Correll has reported relationships with Karuna, as well as AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Axsome, Boehringer-Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Damitsa, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Medscape, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Newron, Noven, Otsuka, Pfizer, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Seqirus, Servier, SK Life Science, Sumitomo Dainippon, Sunovion, Sun Pharma, Supernus, Takeda, Teva, Viatris, Otsuka, and UpToDate.
A version of this article first appeared on Medscape.com.