Scilex Reports Efficacy and Safety Results of Semdexa (SP-102) P-III (C.L.E.A.R.) Program for Sciatica Pain Management
Shots:
- The P-III (C.L.E.A.R.) program evaluates the safety & analgesic effects of a single & repeat transforaminal inj. of SP-102 vs PBO in 401 patients with lumbosacral radicular pain or sciatica
- The results showed that patients experienced a rapid onset of pain relief as measured by NPRS of avg. daily pain in affected leg @ first 4wks., following a single transforaminal inj. The 2EPs of ODI showed a 28% improvement @4wks. on SP-102 over baseline
- The company plans to discuss with the US FDA in 2022 for licensure application & BTD. If SP-102 will be approved by the US FDA, the product will be available in a pre-filled syringe formulation & will be given as an epidural inj. for sciatica
Ref: Sorrento Therapeutics | Image: Scilex
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