Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension

Exclusion Criteria

• •1. Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
• •2. Have a clinically significant abnormal electrocardiogram (ECG) at screening
• •3. Have had any type of gastric bypass surgery or have a gastric band.
• •4. Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus.
• •5. Have a history of any medical condition that would alter the absorption, distribution, metabolism or excretion of COV795
• •6. Have a history of severe bronchial asthma, hypercarbia, or hypoxia
• •7. Have a clinically significant abnormality on their clinical laboratory values
• •8. Have Addison's disease, benign prostatic hyperplasia, or kidney disease
• •9. Have donated blood or blood components within 3 months prior to the screening visit.
• •10. Have a known allergy or hypersensitivity to any opioid analgesics, anesthetics, acetaminophen, Non-steroid anti-inflammatory drugs (NSAIDs).
• •11. Have a history of intolerance to short term opioid use.
• •12. Unwilling to discontinue certain prohibited medications within the allotted time before surgery and throughout the duration of the study. Have taken certain drugs within the indicated times before surgery.
• •13. Have a history of substance or alcohol abuse and/or a positive result on drug screening.
• •14. Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
• •15. Have dysphagia and/or cannot swallow study medication whole.
• •16. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
• •17. Have previously participated in a clinical trial using COV795 or had a bunionectomy in the last 3 months.
• •18. Received any investigational drugs or devices within 4 weeks prior to the screening visit.
• •19. Other criteria as specified in the trial protocol.