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# Acadia’s Phase 3 Trial of Intranasal Carbetocin Fails
- URL: https://www.fdaweb.com/acadias-phase-3-trial-of-intranasal-carbetocin-fails/
- Published: 2025-09-24T12:00:00.000Z
- Updated: 2026-09-14T15:22:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159926

Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for treating hyperphagia in patients with Prader-Willi syndrome (PWS) did not achieve its primary or secondary endpoints.

The 12-week, randomized, placebo-controlled study enrolled 175 children and adults ages 5 to 30 years with PWS. The treatment failed to show a statistically significant improvement over placebo on the primary measure — change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials, the company says, adding that safety results were in line with earlier studies, with a low rate of adverse events.

Prader-Willi syndrome is described by the company as a rare genetic disorder marked by insatiable hunger, obesity, intellectual disability, and behavioral challenges. Hyperphagia, or chronic overeating, is among the most debilitating features of the condition.