Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Exclusion Criteria

• •Clinically significant abnormal clinical laboratory test value
• •Clinically significant 12-lead ECG
• •History of orthostatic hypotension or syncope
• •History of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition
• •History of seizure or currently taking anticonvulsants
• •History of hypersensitivity to bupivacaine/ropivacaine, any other amide-type local anesthetic, propofol, oxycodone or morphine (or other opioids)
• •History of severe or refractory post-operative nausea or vomiting (PONV)
• •Abnormalities of laboratory parameters: HbA1c, platelet, hemoglobin, WBC, serun bilirubin/alanine aminotransferase/aspartate aminotrasferase, serum creatinine, PTT/INR
• •Concurrent acute, or chronic painful restrictive/physical condition
• •Received opioid therapy for longer than 4 days per week
• •Prohibited medication: aspirin and other anti-platelet medication, anticoagulants, class III antiarrhythmic drugs, strong CYP1A2 inhibitors,systemic corticosteroids, NSAID, opioid, bupivacaine or ropivacaine, any investigational product
• •History of drug abuse or alcohol abuse
• •Positive results on the urine drug screen or alcohol breath test
• •History of HIV; active HBV or HCV
• •An inguinal hernia repair in the last 3 months or has undergone 3 or more surgeries within 12 months
• •Malignancy in the last 2 years
• •Documented sleep apnea or on home continuous positive airway pressure treatment (CPAP)
• •Personal or family history of malignant hyperthermia.