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Third Xanomeline-Trospium Trial Shows Improvement in Schizophrenia Symptoms
Xanomeline-trospium chloride was efficacious and well-tolerated in adults with schizophrenia experiencing acute psychosis, according to trial results published in JAMA Psychiatry.
“In the phase 3 EMERGENT-3 trial in people with schizophrenia experiencing acute psychosis, xanomeline-trospium was associated with a statistically significant and clinically meaningful 8.4-point greater reduction in PANSS [Positive and Negative Syndrome Scale] total score compared with placebo at week 5,” wrote corresponding author Steven M. Paul, MD, of Karuna Therapeutics, Boston, Massachusetts, and study coauthors.
The double-blind, 5-week EMERGENT-3 trial took place at 30 inpatient sites in the United States and Ukraine. Among 256 adult patients with schizophrenia experiencing acute psychosis, 125 were randomized to receive xanomeline-trospium and 131 to placebo. Xanomeline-trospium combines a dual M1/M4 preferring muscarinic receptor agonist with a peripherally restricted muscarinic receptor antagonist, researchers explained.
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At week 5, PANSS total scores improved 20.6 points in the xanomeline-trospium group compared with 12.2 points in the placebo group, according to the study.
Discontinuation rates due to treatment-emergent adverse events were 6.4% with xanomeline-trospium and 5.5% with placebo. Adverse events were primarily gastrointestinal, mild or moderate in intensity, and generally transient. Rates were 19.2% for nausea with xanomeline-trospium (vs 1.6% with placebo), 16% for dyspepsia (vs 1.6%), 16% for vomiting (vs 0.8%), and 12.8% for constipation (vs 3.9%). Extrapyramidal symptoms, weight gain, and somnolence were similar between the xanomeline-trospium and placebo groups.
“The efficacy, safety, and tolerability of xanomeline-trospium in EMERGENT-3 were substantially consistent with the results reported for the EMERGENT-1 and EMERGENT-2 trials,” the authors wrote. “Together, these results demonstrate that xanomeline-trospium has the potential to be the first in a new class of antipsychotic medications targeting muscarinic receptors and an alternative to D2 dopamine receptor antagonists.”
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