Final results from a Phase 3 trial evaluating SP-102 (dexamethasone sodium phosphate injection viscous gel) have been announced for the treatment of lumbosacral or sciatica root pain.
SP-102 is a viscous gel formulation of dexamethasone sodium phosphate administered by epidural injection. The experimental product does not contain any preservatives, surfactants, solvents or particles.
The Phase 3 CLEAR trial (ClinicalTrials.gov Identifier: NCT03372161) compared the analgesic effects and safety of single and repeated transforaminal injections of SP-102 with placebo. The trial included 401 adults with a diagnosis of lumbosacral radicular pain. The primary endpoint was the mean change in leg pain scores, using the Numerical Pain Rating Scale, from baseline to week 4. Primary secondary endpoints included change in Oswestry Disability Index (ODI) score and time to repeat open-label injection.
After a single injection of SP-102, results showed a least squares (LS) mean group difference (SE) of -1.08 (0.17) for the change in mean daily pain in the affected leg over 4 weeks versus placebo (P <.001 patients treated with sp-102 reported pain relief beyond weeks the median time to repeat open injection was days ci as estimated by kaplan-meier.>
SP-102 treatment was also associated with a 28% improvement in ODI score at 4 weeks from baseline. The group mean LS difference (SE) in ODI score was -6.28 (1.49) from placebo at week 4 (P <.001>
Additionally, statistically significant results were reported for other secondary endpoints including Global Impression of Change, Brief Pain Inventory, PainDETECT, and cumulative rescue medication use (acetaminophen).
Regarding safety, there were no serious adverse events related to SP-102 or the injection procedure, and no adverse events of special interest were reported (e.g. hematoma, infection injection site, paraplegia).
“We are very pleased with the positive outcome and the results of these trials are very remarkable,” said Dmitri Lissin, MD, Chief Medical Officer of Scilex. “We believe that SP-102 (SEMDEXA™) has the potential to be a transformative treatment option for sciatica, an area that has seen no significant advances in therapies that patients and physicians have sought for decades. .”
The Food and Drug Administration (FDA) previously granted SP-102 Fast Track designation for this indication.
Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc., announces final efficacy and safety results of SP-102 (Semdexa™) from its pivotal Phase 3 clinical trial program for the management sciatic pain, supporting the potential for a first-to-market opportunity. Press release. Sorrento Therapeutics, Inc. Accessed March 22, 2022. https://www.globenewswire.com/news-release/2022/03/18/2406054/0/en/Scilex-Holding-Company-a-majority-owned-subsidiary-of-Sorrento-Therapeutics-Inc-Announces- Final-Results-for-SP-102-SEMDEXA-Efficacy-and-Safety-from-its-Pivotal-Phase-3-Clinical-Tri.html