Scilex Holding Company has presented a comprehensive post-hoc analysis of their C.L.E.A.R. (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) trial, revealing clinically meaningful safety and efficacy data for SP-102 (SEMDEXA™) in the treatment of lumbosacral radicular pain (LRP), commonly known as sciatica. The findings were showcased at the 27th Annual Meeting of the American Society of Interventional Pain Physicians (ASIPP) held May 15-17, 2025, in Orlando, Florida.
Key Findings from the Post-Hoc Analysis
The analysis, titled "Interpreting Clinical Meaningfulness of SP-102 for the Treatment of Lumbosacral Radicular Pain (LRP): A Post-hoc Analysis of the CLEAR-1 Trial and A Systematic Review of Literature," was authored by a team including Miller AM, Knezevic NN, Nalamachu S, Meske D, Ambrose C, Vought K, Chan EK, and Lissin D.
According to the presented data, SP-102 demonstrated "clear clinically meaningful separation" from placebo across multiple within-subject endpoints, including Numeric Pain Rating Scale (NPRS) Responder Analyses, Oswestry Disability Index (ODI), and Brief Pain Inventory (BPI) Pain Interference. Notably, these positive results were further enhanced when analyzing the modified intent-to-treat (mITT) population, which included only patients confirmed by independent experts to have received the study drug.
The analysis also evaluated the standard effect size of SP-102 compared to other marketed and approved analgesics for chronic low back pain (CLBP) and other transforaminal steroid injections (TSIs), with favorable results supporting SP-102's clinical value.
Safety Profile and Formulation Advantages
A significant highlight of the presentation was the safety profile of SP-102. The formulation was specifically designed to offer a safer alternative to current off-label products used for similar indications, which often carry warnings about potentially dangerous and life-threatening adverse events.
"Collectively, the benefit-risk profile presented supports SP-102 being a safe and efficacious product that has the potential to offer much-needed therapy for the treatment of LRP," stated the company in their announcement.
Clinical Meaningfulness Assessment Methodology
The researchers emphasized that interpreting clinical meaningfulness requires consideration of both primary and secondary endpoints assessed within subjects based on consensus benchmarks, as well as between-group differences in the context of overall risk-benefit profiles and comparisons to other approved products for similar indications.
This comprehensive approach to evaluating clinical meaningfulness provides a more holistic understanding of SP-102's potential value in the treatment landscape for lumbosacral radicular pain.
About SP-102 (SEMDEXA™)
SP-102 is a novel, viscous gel formulation of dexamethasone sodium phosphate (10 mg) designed specifically for epidural injections to treat lumbosacral radicular pain, or sciatica. The product has completed Phase 3 clinical trials and received Fast Track designation from the FDA in 2017, highlighting its potential to address significant unmet needs in pain management.
The gel formulation represents an innovation in the delivery of corticosteroids for epidural administration, potentially offering improved safety and efficacy compared to current options.
Scilex's Non-Opioid Pain Management Portfolio
Scilex Holding Company, headquartered in Palo Alto, California, focuses on developing non-opioid pain management products for acute and chronic pain, as well as treatments for neurodegenerative and cardiometabolic diseases. The company's current commercial portfolio includes ZTlido® (lidocaine topical system) 1.8% for postherpetic neuralgia, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis.
In addition to SP-102, Scilex's pipeline includes SP-103 (lidocaine topical system) 5.4%, a triple-strength formulation of ZTlido for acute pain that has completed Phase 2 trials and received Fast Track status for low back pain, and SP-104, a novel low-dose delayed-release naltrexone hydrochloride being developed for fibromyalgia.
Publication and Accessibility
The poster presentation will be published in the Pain Physician journal, further expanding the reach of these findings to the broader medical community. During the ASIPP meeting, the poster was displayed from May 15-17, 2025, and was also made available through the conference app.
This publication in a peer-reviewed journal will provide the medical community with detailed insights into the clinical meaningfulness of SP-102 for lumbosacral radicular pain treatment, potentially influencing future treatment guidelines and clinical practice.
Implications for Sciatica Treatment
Lumbosacral radicular pain, commonly known as sciatica, affects millions of patients worldwide and represents a significant burden on healthcare systems. Current treatment options often include off-label use of corticosteroid injections, which may carry safety concerns.
The positive findings from this post-hoc analysis suggest that SP-102 could potentially offer a safer and efficacious alternative for patients suffering from this debilitating condition, addressing an important unmet need in pain management while potentially reducing reliance on opioid medications.
As Scilex continues to advance SP-102 through the regulatory pathway, these findings provide important context for understanding the potential clinical value of this novel treatment approach for lumbosacral radicular pain.
