HTX-011 in Spinal Surgery

A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery

This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.

Inclusion Criteria:

• Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
• Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

Exclusion Criteria:

• Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
• Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
• Has functioning intrathecal drug pump or spinal cord stimulator.
• Opioid use for most days within the last 3 months.
• Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery.
• Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
• Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.
• Has impaired balance and is at risk of falling.
• Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
• Has undergone 3 or more surgeries within 12 months.
• Has a known history of glucose-6-phosphate dehydrogenase deficiency.
• Has History of liver cirrhosis, having an aspartate aminotransferase >3 × the upper limit of normal (ULN), or having an alanine aminotransferase >3 × ULN.