Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

Exclusion Criteria

• •Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain and other symptoms of CLBP or increase the risk of opioid-related adverse events
• •A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug
• •A surgical procedure for back pain within 6 months
• •A nerve or plexus block, including epidural steroid injections or facet blocks
• •A history of chemotherapy or confirmed malignancy within past 2 years
• •Any other chronic pain condition other than CLBP that, in the Investigator's opinion, would interfere with the assessment of LBP e.g. fibromyalgia, osteoarthritis, rheumatoid arthritis, migraine headaches requiring opioid treatment
• •Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure \>180 mmHg or \<90 mmHg, and/or a sitting diastolic blood pressure \>120 mmHg or \<50 mmHg at Screening
• •A Body Mass Index (BMI) \>45 kg/m2
• •A Hospital Anxiety and Depression Scale (HADS) Index score of \>12 in either depression or anxiety subscales or an established history of major depressive disorder that is poorly controlled with medication
• •A clinically significant abnormality in clinical chemistry, hematology or urinalysis