Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy

Summary

To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain

Timeline

Start

2021-03-29

Primary completion

2022-02-11

Completion

2022-03-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Drug - ACP-044 400 mg Q6H vs Placebo; p = 0.1683; LSM difference -10.5 (95% CI -25.4 to 4.4); ANOVA NCT04855240 ↗

registry analysis (superiority test); Drug - ACP-044 1600 mg QD vs Placebo; p = 0.8356; LSM difference 1.6 (95% CI -13.4 to 16.6); ANOVA NCT04855240 ↗

release “We are disappointed that the ACP-044 bunionectomy study did not meet its primary endpoint” acadia.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EBARESDAX	Small molecule	—	Oral

Indications

No indication recorded.