Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Exclusion Criteria

• •Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
• •Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
• •History of infection in the index knee
• •Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
• •Unstable joint within 12 months of screening
• •IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• •IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• •Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
• •Any other IA investigational drug/biologic within 6 months of Screening
• •Prior use of FX006
• •Women of child-bearing potential not using effective contraception or who are pregnant or nursing