Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,
 multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via
 local administration into the surgical site in subjects undergoing bunionectomy.
Inclusion Criteria:

 -  Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy
 with 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 to
 become 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 or collateral
 procedures on the surgical foot).

 -  Has other pre existing concurrent acute or chronic painful physical/restrictive
 condition expected to require analgesic treatment in the postoperative period for
 pain.

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

 -  Has known or suspected daily use of opioids for 7 or more consecutive days within the
 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 for
 long-acting).

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

 -  Has initiated treatment with medications within 1 month prior to study drug
 administration that can impact pain control.

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

 -  Has a medical condition such that, in the opinion of the Investigator, participating
 in the study would pose a health risk to the subject or confound the postoperative
 assessments.

 -  As per subject history and/or medical records, has active infection or is currently
 undergoing 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 or
 squamous 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 of
 surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug
 screen who are taking an allowed, prescribed medication that is known to result in a
 positive drug test (eg, amphetamine and dextroamphetamine for attention
 deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible
 for participation in the study. Subjects taking medical marijuana are not allowed to
 participate in the study.

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

 -  Has undergone 3 or more surgeries within 12 months.

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