Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

Exclusion Criteria

• •Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics
• •Is pregnant or lactating
• •Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening
• •Has a BMI greater than 40 kg/m2
• •Has radiological evidence of clinically significant foraminal stenosis at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
• •Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
• •Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain
• •Has had lumbar back surgery
• •Has received an implantable device for pain management