XG005 for Pain Control in Subjects Undergoing Bunionectomy

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy

This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg XG005, 1250 mg XG005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. Subjects and all study staff performing study assessments will be blinded to treatment allocation. Subjects will be discharged at a reasonable hour of the day after the end of the 72-hour treatment period.There will be a Follow-up Visit on Day 15.

Main inclusion criteria:

• Scheduled to undergo unilateral first metatarsal bunionectomy
• Have negative urine drug screen
• Non-pregnant, non-lactating

Main exclusion criteria:

• Medical condition or history that in the investigator's opinion could adversely impact the subject's participation or safety
• Use of disallowed medications (e.g. pain medication, CNS active drugs such as benzodiazepines, tricyclic antidepressants, Serotonin, and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), or any other serotonergic medications, parenteral or oral corticosteroids)
• Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days
• Digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics
• Monoamine oxidase inhibitors (MAOIs)
• Positive HbsAg and/or anti-HBc but negative anti-HBs
• HIV infection
• History of illicit drug use
• History of opioid dependence
• History of NSAID-induced bronchospasm or presence of nasal polyps, history of asthma or chronic rhinitis
• Significant history of allergic reactions or known intolerance to naproxen, pregabalin or any gabapentinoid, or to any rescue medication used in the study, or any medication used in the surgical and anesthetic protocol.
• Presence of severe depression as indicated by Patient Health Questionnaire (PHQ 9) total score of ≥20 or item 9 score >0
• Presence of severe anxiety as indicated by General Anxiety Disorder (GAD-7) score of ≥15
• Presence of history of suicidal behavior or ideation as indicated by the C-SSRS