Flurbiprofen Tape for Treatment of Chronic Low Back Pain

Inclusion Criteria: * male or female 18 to 80 years; * signed an informed consent; * daily LBP below the 12th thoracic vertebra of greater than 3 months' duration; * able to ambulate at least 100 meters; * in stable general health with laboratory values within normal limits * no evidence of drug abuse or residual opiates; determined by urine drug screening; * diagnosis of chronic LBP verified by medical records; * female patients must be postmenopausal (defined as 1 year without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Non-postmenopausal patients must have confirmation of a negative urine pregnancy test; * must read and speak English; * must be reliable and mentally competent to complete study measurements; * must be available for the study visits and telephone checks from study entry to study completion. * male patients must use an acceptable method of birth control with their female partners; * rates their pain at 3 or higher on an 11-point Categorical Pain Scale for LBP over the prior week (7 days) of Visit 1. * over the last 3 days of the Baseline Phase, had a computed average pain score of 4 or greater on an 11-point Categorical Pain Scale * discontinued the use of any topical pain medications, salves, anticonvulsants, oral NSAIDs, muscle relaxants, opioids, or anti-inflammatory steroids during the Baseline Phase. Acetaminophen, at a dose of ≤ 1000 mg per day is acceptable; * able to discontinue the use of therapy defined as ice, heat, chiropractic care, physical therapy, acupuncture and acupressure on their lower back area during the Baseline Phase. Exclusion Criteria: * open skin lesion within the painful area; * experiencing LBP for less than 3 months; * undergone back surgery within the past 3 months or has plans for back surgery within 30 days post-study; * participated in clinical treatment studies within 30 days of study entry; * chronic back pain which is due to fibromyalgia or connective tissue disorder (lupus, rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, etc.); * LBP due to malignancy, vertebral fracture, or infection; * used opioids (including low potency/low dose opioid combinations and tramadol) more than 2 times per week within 30 days of study entry. Opioids and tramadol must not have been taken at least 4 days prior to study entry; * had injection therapy within 30 days of study entry, including corticosteroids; * a clinically significant psychiatric disorder (severe depression, other Axis I or Axis II disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV); * taking lithium, furosemide, and/or thiazides; * considered unreliable as to medication compliance (if any medication other than 1000 mg or less of acetaminophen a day was taken for any type of pain, the patient was discontinued) or adherence to scheduled appointments as determined by the investigators; * a prior history of GI bleeds/ulcers or clinically significant liver/kidney disease; * known hypersensitivity to flurbiprofen or other NSAIDs; * has a coagulation disorder or is taking warfarin or other anticoagulants (aspirin at a dose of \[≤ 81 mg\] is acceptable); * clinically significant fluid retention, cardiovascular disease (CVD), hypertension, or heart failure; * had coronary artery bypass graft surgery (CABG), cardiovascular thrombotic event, myocardial infarction (MI) and/or stroke within 1 year of Visit 1; * had unresolved litigation related to back injury or other pain complaints; settled disability claims/payments (Worker's Compensation, state/federal/private disability plans) were allowed.