Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

Inclusion Criteria:

- Diagnosis of moderate to severe low back pain for ≥6 months

- Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication
up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as
needed [PRN] non-opioid analgesic medications permitted on top of the stable daily
maintenance dose of non-opioid analgesic)

- Stable health, as determined by Principal Investigator

- Are female who are practicing abstinence or using a medically acceptable form of
contraception or have been post-menopausal, biologically sterile, or surgically
sterile for more than 1 year

- Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

- Current cancer related pain or received chemotherapy with 6 months of screening

- Receiving opioid analgesic medication >10 mg MSE per day within 28 days of screening

- Subjects with a history of other chronic painful conditions

- Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda
equina compression, acute nerve root compression, meningitis, or discitis

- Allergy or contraindications to any opioid or acetaminophen

- Surgical procedure for relief of pain with 6 months

- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial
fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active
myocardial ischemia

- QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the
12-lead electrocardiogram (ECG)

- History of long QT syndrome or a family member with this condition

- Moderate to severe hepatic impairment

- Moderate to severe renal impairment

- Current or past history of alcohol abuse

- Positive urine toxicology screen for drug of abuse

- History or abnormalities on physical exam, vital signs, electrocardiogram, or
laboratory values