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

Exclusion Criteria

• •Has had a contralateral foot bunionectomy in the past 3 months
• •Has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral procedures like hammertoe correction on the surgical foot)
• •Any subacute or chronic pain condition or use of a medication that would impair/impact the ability to rate the pain associated with the bunionectomy, in the opinion of the Investigator and Medical Monitor
• •Has known or suspected regular use of opioids within the previous 6 months
• •Has taken opioids within 24 hours prior to the scheduled surgery or within five half-lives of the drug, whichever is longer
• •Has a known or suspected history of drug abuse, a positive drug screen at Screening or Day -1, or a recent (i.e., within the last 5 years) history of alcohol abuse. Subjects using marijuana are not allowed to participate in the study.
• •Has taken any aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 days prior to the scheduled surgery or within five half-lives of the drug, whichever is longer
• •Has initiated treatment with any medications within 1 month prior to study drug administration that could impact pain control or quantitation of their pain response
• •Has been administered systemic steroids within five half-lives or 10 days prior to administration of study drug, whichever is longer
• •Has current evidence, or medical history of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, endocrinologic, or other medical disorder, within the previous 12 weeks prior to Screening and on Day -1, that in the judgment of the Investigator and/or Medical Monitor would jeopardize the safe participation of the subject in the study. Also, subject must not have had a malignancy in the last year, with the exception of nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix.
• •Is judged by the Investigator or the Medical Monitor to be inappropriate for the study