Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain

Inclusion criteria

• Is an English-speaking man or woman between 18 and 75 years of age who has given written informed consent.
• Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months.
• Is opioid naïve (ie, taking <20 mg oxycodone/day or opioid equivalent) or is opioid experienced (ie, taking a dose between 20 and 240 mg [inclusive] oxycodone/day or opioid equivalent) for management of moderate-to-severe CLBP at least 14 days prior to screening and will, in the opinion of the investigator, continue to require opioid therapy (between 20 and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe CLBP for the duration of the study.
• Has stable health, as determined by the investigator,
• If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening and throughout the duration of the study), or is of non-childbearing potential

Exclusion criteria

• Has cancer-related pain.
• Has a history of receiving >240 mg oxycodone (or equivalent) daily within 30 days before screening.
• Has a lumbar spinal infusion pump in use or used within 6 months before screening.
• Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia)
• Has positive urine drug toxicity screen for illegal or non-prescribed drugs
• Has current (or history of within the last 5 years prior to screening) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
• Has positive result for cannabinoids (even if legally prescribed).
• Has a history of attempted suicide.