Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

Inclusion Criteria:

• Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomywith osteotomy and internal fixation under regional anesthesia.

• Has an American Society of Anesthesiologists Physical Status of I, II, or III.

• Female subjects are eligible only if not pregnant, not lactating, not planning tobecome pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

• Has had a contralateral foot bunionectomy in the past 3 months.

• Has a planned concurrent surgical procedure (eg, bilateral bunionectomy orcollateral procedures on the surgical foot).

• Has other pre existing concurrent acute or chronic painful physical/restrictivecondition expected to require analgesic treatment in the postoperative period forpain.

• Has a contraindication or a known or suspected history of hypersensitivity orclinically significant idiosyncratic reaction to required study medications.

• Has known or suspected daily use of opioids for 7 or more consecutive days withinthe previous 6 months.

• Has taken any NSAIDs within at least 10 days prior to the scheduled surgery.

• Has taken opioids within 24 hours prior to the scheduled surgery (3 days forlong-acting).

• Has been administered bupivacaine within 5 days prior to the scheduled surgery.

• Has initiated treatment with medications within 1 month prior to study drugadministration that can impact pain control.

• Has been administered systemic steroids within 5 half-lives or 10 days prior toadministration of study drug.

• Has a medical condition such that, in the opinion of the Investigator, participatingin the study would pose a health risk to the subject or confound the postoperativeassessments.

• As per subject history and/or medical records, has active infection or is currentlyundergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).

• Has uncontrolled anxiety, psychiatric, or neurological disorder.

• Had a malignancy in the last year, with the exception of nonmetastatic basal cell orsquamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

• Has a known or suspected history of drug abuse, a positive drug screen on the day ofsurgery, or a recent history of alcohol abuse. Note: Subjects with a positive drugscreen who are taking an allowed, prescribed medication that is known to result in apositive drug test (eg, amphetamine and dextroamphetamine for attentiondeficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligiblefor participation in the study. Subjects taking medical marijuana are not allowed toparticipate in the study.

• Received an investigational product or device in a clinical trial within 30 days orwithin 5 elimination half lives.

• Has undergone 3 or more surgeries within 12 months.

• Has a body mass index (BMI) >39 kg/m2.