SRNE - Sorrento subsidiary reports positive SP-102 results from late-stage sciatica pain study
Sorrento Therapeutics' (SRNE) subsidiary Scilex Holding Company announces positive top-line results from its SP-102 (SEMDEXA) Phase 3 Trial C.L.E.A.R. Program, a corticosteroid injectable dexamethasone sodium phosphate viscous gel for the treatment of lumbosacral radicular pain, or sciatica. C.L.E.A.R. Trial (Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy) was designed to investigate safety and analgesic effects of a single and repeat transforaminal injections of SP-102 compared to placebo (saline injection). The trial enrolled 401 low back pain subjects with unilateral intervertebral disc herniation in lumbosacral spine resulting in radicular pain symptoms of moderate to severe leg pain. The primary endpoint of change in average daily pain in the affected leg over 4 weeks following the initial injection had demonstrated LS Mean (SE) group difference of -1.08 (0.17) compared to placebo with a p-value <0.001. The two key secondary endpoints assessing Oswestry Disability Index (ODI) and Time to open-label repeat injection had also demonstrated highly
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Sorrento subsidiary reports positive SP-102 results from late-stage sciatica pain study