Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.

Inclusion Criteria:

• Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation
• Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.

Exclusion Criteria:

• Participated in another oliceridine clinical study.
• Received any investigational drug, device or therapy within 35 days before surgery.
• Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.
• American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.