The Food and Drug Administration (FDA) has granted Fast Track designation to SP-102 (injectable dexamethasone sodium phosphate viscous gel) for the treatment of lumbosacral radicular pain, or sciatica.
SP-102 is a dexamethasone sodium phosphate viscous gel that is administered by epidural injection. The designation is supported by data from the phase 3 C.L.E.A.R. trial (ClinicalTrials.gov Identifier: NCT03372161), which compared the analgesic effects and safety of single and repeat transforaminal injections of SP-102 with placebo.
The trial included 401 adults with low back pain who have unilateral intervertebral disc herniation in lumbosacral spine resulting in radicular pain symptoms of moderate to severe leg pain. The primary endpoint was the mean change in leg pain scores, using the Numerical Pain Rating Scale, from baseline to week 4. Key secondary endpoints included change in the Oswestry Disability Index (ODI) score and the time to open-label repeat injection.
Findings demonstrated a least square (LS) mean (SE) group difference of -1.08 (0.17) for the change in average daily pain in the affected leg over 4 weeks compared with placebo (P <.001). The LS mean (SE) group difference in ODI score was reported to be -6.28 (1.49) compared with placebo at week 4 (P <.001).
Additionally, patients with moderate to severe radicular pain were eligible to receive an open-label repeat injection of SP-102 after the initial 4-week observation period. Repeat injections were administered to 67% of patients who initially received placebo and 46% of patients who initially received SP-102. A Cox proportional hazard model showed significantly longer duration of initial SP-102 treatment compared with placebo (hazard ratio, 0.49; 95% CI, 0.36-0.65; P <.001).
“These highly significant positive clinical results for the pivotal SP-102 (Semdexa™) phase 3 trial may provide encouraging news for the many millions of people worldwide who are confronting painful radicular pain (sciatica) and we look forward to sharing complete phase 3 results next year,” said Jaisim Shah, President and Chief Executive Officer of Scilex. “We believe that SP-102 (Semdexa™) could be the first FDA-approved epidural steroid gel injection product for patients suffering from this common, very painful condition.”
Scilex Holding Company, a Sorrento Therapeutics, Inc. Subsidiary, announces highly significant positive top-line results from its phase 3 non-opioid injectable SP-102 (Semdexa™) pivotal trial C.L.E.A.R. program for sciatica pain management supporting the potential use of SP-102 as a best-in-class therapy. News release. Sorrento Therapeutics, Inc. Accessed December 9, 2021. https://www.globenewswire.com/news-release/2021/12/09/2349302/0/en/Scilex-Holding-Company-a-Sorrento-Therapeutics-Inc-Subsidiary-Announces-Highly-Significant-Positive-Top-Line-Results-from-its-Phase-3-Non-Opioid-Injectable-SP-102-SEMDEXA-Pivotal-T.html.