Acadia’s Phase 3 Trial of Intranasal Carbetocin Fails

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.