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

Main Inclusion Criteria: * Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study * Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy. * Mean Worst Daily Leg Pain score of ≥5.0 and ≤9.0 * Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing Main 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 re…