A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

Key Inclusion Criteria Before Surgery:

• Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomyand internal fixation with no collateral procedures, using anesthesiologic andsurgical procedures planned.

• Must be able to adhere to the visit schedule, complete all study assessments andprotocol requirements, including self-reported questionnaires.

Key Exclusion Criteria Before Surgery:

• Any clinically significant disease, medical condition, or laboratory finding that inthe investigator's opinion may interfere with the study procedures or dataintegrity, or compromise the safety of the subject.

• Secondary (i.e., unrelated to bunion) current painful condition that could confoundthe interpretation of efficacy, safety, or tolerability data in the study, in theopinion of the investigator.

• Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painfulcondition that might impact the subject's ability to properly assess theirpostoperative pain, or that may require treatment during the Treatment Phase.

• History of allergy or hypersensitivity to any opioid analgesics, anesthetics,ibuprofen, or other NSAIDs.

Immediate Postoperative Exclusion Criteria:

• Surgical, postsurgical, or anesthetic complication that could confound theinterpretation of efficacy, safety, or tolerability data in the study.

• Deviation from the surgical, postsurgical, or anesthetic protocol that couldconfound the interpretation of efficacy, safety, or tolerability data in the study.

• Evidence of hemodynamic instability or respiratory insufficiency.