A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

Exclusion Criteria

• •subject will be excluded from the study if any of the following criteria are met:
• •1. Has clinically significant allergies to an opioid, unless has subsequently tolerated other opioids and, in the opinion of the Investigator, could tolerate a rescue drug containing oxycodone.
• •2. Has a known or suspected allergy to any local anesthetic or to acetaminophen.
• •3. Has a known or suspected history of alcohol, opiate or other drug abuse or dependence within 12 months prior to screening.
• •4. Is unable to refrain from alcohol consumption for a period beginning 24 hours prior to surgery through the end of the 72 -hour evaluation period.
• •5. Has taken any analgesic or non-opioid pain medication other than acetaminophen (e.g., NSAIDs, cyclooxygenase-2 \[COX 2\] inhibitors) within 12 hours prior to surgery or any aspirin-containing product within 7 days of the Baseline assessments. Aspirin up to 325 mg once daily for cardiovascular prophylaxis is allowed.
• •6. Has taken any opioid analgesics or used systemic steroids within 4 days of surgery.
• •7. Has been using opiates or any non-steroidal anti-inflammatory drug chronically (more than 10 consecutive days) anytime over the past 3 months.
• •8. Has used antipsychotics or antiepileptics within 30 days prior to surgery. Use of sedatives, hypnotics, antianxiety agents, and antidepressants (other than monoamine oxidase inhibitors \[MAOIs\]) are allowed if being used for a nonpain indication and at a stable dose within the previous 30 days.
• •9. Has history of or positive test results for HIV or hepatitis B or C at Screening.
• •10. Has any history of epilepsy, other than childhood febrile seizures, before the age of 6.
• •11. Has any history of psychosis, current clinically significant symptomatic psychiatric disorder, or a history of suicide attempt in the past 10 years.
• •12. Has taken herbal agents or nutraceuticals (e.g., chapparal, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) during any of the 7 days prior to surgery that could potentially confound the analgesic response in the Investigator's opinion.
• •13. Has transaminase levels \> 2 x ULN, or bilirubin level \> 1.5 x ULN (unless Gilbert's syndrome), or estimated glomerular filtration rate (eGFR) \< 60 mL/min. Has poorly controlled diabetes with hemoglobin A1c \>7.5%.
• •15\. Has any clinically significant condition including an acute or chronic painful physical restrictive condition or any other significant laboratory abnormality that would, in the opinion of the Investigator, confound study assessments or adversely affect subject safety. 16. Has received another investigational drug within 30 days of scheduled surgery.