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# Disappointing Data in Schizophrenia Drug: AbbVie
- URL: https://www.fdaweb.com/disappointing-data-in-schizophrenia-drug-abbvie/
- Published: 2024-11-11T12:00:00.000Z
- Updated: 2026-09-14T14:46:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158158

AbbVie says its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms did not meet their primary endpoint. Specifically, the trials did not show a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale total score compared to the placebo group at Week 6\. “While we are disappointed with the results, we are continuing to analyze the data to determine next steps,” the company says.

In the trials, emraclidine was said to be well-tolerated with a safety profile comparable to that observed in the Phase 1b trial. The most commonly reported adverse events were headache (9.4% and 10.8% in placebo), dry mouth (2.3% and 0.8% in placebo), and dyspepsia (3.1% and 1.5% in placebo), AbbVie says.