Scilex Holding Company Presented Post-Hoc Analysis of the C.L.E.A.R. Trial on Clinical Meaningfulness of Safety and Efficacy of SP-102 for the Treatment of Lumbosacral Radicular Pain (LRP) at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP), May 15-17, 2025 in Orlando, FL
Scilex Holding Company (NASDAQ: SCLX) presented a post-hoc analysis of their C.L.E.A.R. trial at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP). The analysis focused on interpreting the clinical meaningfulness of SP-102 (SEMDEXA™) for treating lumbosacral radicular pain (LRP).
The results demonstrated that SP-102 showed clinically meaningful separation from placebo across multiple endpoints, including NPRS Responder Analyses, ODI, and BPI Pain Interference. The effectiveness was particularly notable in the modified intent-to-treat (mITT) population. When compared to other marketed analgesics for chronic low back pain and TSIs, SP-102's standard effect size showed promising results.
The drug was specifically formulated to provide a safer alternative to current off-label products that carry warnings of potentially dangerous and life-threatening adverse events. The overall benefit-risk profile suggests SP-102 could be a safe and effective treatment option for LRP patients.
Scilex Holding Company (NASDAQ: SCLX) ha presentato un'analisi post-hoc del loro studio C.L.E.A.R. durante il 27° Congresso Annuale della American Society of Interventional Pain Physicians (ASIPP). L'analisi si è concentrata sull'interpretazione della rilevanza clinica di SP-102 (SEMDEXA™) nel trattamento del dolore radicolare lombo-sacrale (LRP).
I risultati hanno dimostrato che SP-102 ha mostrato una separazione clinicamente significativa rispetto al placebo su più parametri, inclusi gli Analisi dei Rispondenti NPRS, ODI e BPI Pain Interference. L'efficacia è stata particolarmente evidente nella popolazione modificata intent-to-treat (mITT). Rispetto ad altri analgesici presenti sul mercato per il dolore lombare cronico e le iniezioni spinali terapeutiche (TSI), la dimensione dell'effetto standard di SP-102 ha mostrato risultati promettenti.
Il farmaco è stato specificamente formulato per offrire un'alternativa più sicura ai prodotti off-label attualmente utilizzati, che presentano avvertenze riguardo a eventi avversi potenzialmente pericolosi e letali. Il profilo beneficio-rischio complessivo suggerisce che SP-102 potrebbe rappresentare un'opzione terapeutica sicura ed efficace per i pazienti con LRP.
Scilex Holding Company (NASDAQ: SCLX) presentó un análisis post-hoc de su ensayo C.L.E.A.R. en la 27ª Reunión Anual de la American Society of Interventional Pain Physicians (ASIPP). El análisis se centró en interpretar la relevancia clínica de SP-102 (SEMDEXA™) para el tratamiento del dolor radicular lumbosacro (LRP).
Los resultados demostraron que SP-102 mostró una separación clínicamente significativa respecto al placebo en múltiples puntos finales, incluyendo los análisis de respondedores NPRS, ODI y BPI Pain Interference. La efectividad fue especialmente destacada en la población modificada por intención de tratar (mITT). En comparación con otros analgésicos comercializados para el dolor lumbar crónico y las inyecciones espinales terapéuticas (TSI), el tamaño del efecto estándar de SP-102 mostró resultados prometedores.
El medicamento fue formulado específicamente para ofrecer una alternativa más segura a los productos off-label actuales, que conllevan advertencias sobre eventos adversos potencialmente peligrosos y mortales. El perfil beneficio-riesgo general sugiere que SP-102 podría ser una opción de tratamiento segura y eficaz para pacientes con LRP.
Scilex Holding Company (NASDAQ: SCLX)는 제27회 미국 중재 통증 의학회(ASIPP) 연례회의에서 C.L.E.A.R. 임상시험의 사후 분석 결과를 발표했습니다. 이 분석은 요천추 신경근통(LRP) 치료를 위한 SP-102 (SEMDEXA™)의 임상적 의미를 해석하는 데 중점을 두었습니다.
결과는 SP-102가 NPRS 반응자 분석, ODI, BPI 통증 간섭 등 여러 평가 지표에서 위약 대비 임상적으로 의미 있는 차이를 보였음을 입증했습니다. 특히 수정된 의도 치료 인구(mITT)에서 효과가 두드러졌습니다. 만성 요통 및 척추 내 주사(TSI)에 사용되는 다른 시판 진통제와 비교할 때, SP-102의 표준 효과 크기는 유망한 결과를 나타냈습니다.
이 약물은 잠재적으로 위험하고 생명을 위협할 수 있는 부작용 경고가 있는 기존의 비승인(off-label) 제품에 대한 더 안전한 대안을 제공하기 위해 특별히 개발되었습니다. 전반적인 이익-위험 프로필은 SP-102가 LRP 환자에게 안전하고 효과적인 치료 옵션이 될 수 있음을 시사합니다.
Scilex Holding Company (NASDAQ : SCLX) a présenté une analyse post-hoc de leur essai C.L.E.A.R. lors de la 27e réunion annuelle de l'American Society of Interventional Pain Physicians (ASIPP). Cette analyse s'est concentrée sur l'interprétation de la pertinence clinique de SP-102 (SEMDEXA™) pour le traitement de la douleur radiculaire lombo-sacrée (LRP).
Les résultats ont démontré que SP-102 présentait une séparation cliniquement significative par rapport au placebo sur plusieurs critères, notamment les analyses des répondeurs NPRS, ODI et BPI Pain Interference. L'efficacité était particulièrement marquée dans la population en intention de traiter modifiée (mITT). Comparé à d'autres analgésiques commercialisés pour la lombalgie chronique et les injections spinales thérapeutiques (TSI), la taille d'effet standard de SP-102 a montré des résultats prometteurs.
Le médicament a été spécifiquement formulé pour offrir une alternative plus sûre aux produits hors AMM actuels, qui comportent des avertissements concernant des effets indésirables potentiellement dangereux et mortels. Le profil bénéfice-risque global suggère que SP-102 pourrait être une option de traitement sûre et efficace pour les patients souffrant de LRP.
Scilex Holding Company (NASDAQ: SCLX) präsentierte eine Post-hoc-Analyse ihrer C.L.E.A.R.-Studie auf dem 27. Jahreskongress der American Society of Interventional Pain Physicians (ASIPP). Die Analyse konzentrierte sich darauf, die klinische Relevanz von SP-102 (SEMDEXA™) zur Behandlung von lumbosakralem radikulärem Schmerz (LRP) zu interpretieren.
Die Ergebnisse zeigten, dass SP-102 im Vergleich zu Placebo über mehrere Endpunkte hinweg eine klinisch bedeutsame Abgrenzung erzielte, darunter NPRS Responder-Analysen, ODI und BPI Pain Interference. Die Wirksamkeit war besonders ausgeprägt in der modifizierten Intention-to-Treat-Population (mITT). Im Vergleich zu anderen zugelassenen Analgetika für chronische Rückenschmerzen und TSI zeigte die Standard-Effektgröße von SP-102 vielversprechende Ergebnisse.
Das Medikament wurde speziell entwickelt, um eine sicherere Alternative zu den derzeit off-label verwendeten Produkten zu bieten, die Warnhinweise auf potenziell gefährliche und lebensbedrohliche Nebenwirkungen tragen. Das Gesamt-Nutzen-Risiko-Profil deutet darauf hin, dass SP-102 eine sichere und wirksame Behandlungsoption für LRP-Patienten sein könnte.
- SP-102 demonstrated clinically meaningful superiority over placebo in multiple endpoints
- Drug shows promising standard effect size compared to other marketed analgesics
- Offers potentially safer alternative to current off-label treatments
- Favorable benefit-risk profile for LRP treatment
- None.
Insights
Scilex's post-hoc analysis shows SP-102 demonstrated clinical meaningfulness with favorable safety for lumbosacral radicular pain treatment.
The presentation of the C.L.E.A.R. trial post-hoc analysis provides important evidence supporting Scilex's SP-102 (SEMDEXA™) as a potential non-opioid treatment option for lumbosacral radicular pain (LRP). The data demonstrates clinically meaningful separation between SP-102 and placebo across multiple endpoints including NPRS Responder Analyses, ODI, and BPI Pain Interference. This separation became even more pronounced when focusing specifically on the modified intent-to-treat population (mITT) that confirmed drug administration.
What makes this particularly significant is the comparative analysis showing SP-102's standard effect size favorably compares to other marketed analgesics for chronic low back pain and other therapeutic spinal injections (TSIs). The company has strategically developed SP-102's formulation to provide a safer alternative to current off-label products that carry warnings about potentially dangerous adverse events.
This analysis strengthens Scilex's regulatory position by demonstrating both efficacy and safety advantages. For a company focused on non-opioid pain management, these results support their core business strategy of developing alternatives with improved benefit-risk profiles. The data presentation at the American Society of Interventional Pain Physicians annual meeting provides visibility to key clinicians who would potentially prescribe the product if approved. The comprehensive benefit-risk assessment suggests SP-102 could potentially fill an important therapeutic gap for LRP patients seeking safer treatment options.
PALO ALTO, Calif., May 16, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today presented the presentation of post-hoc analysis of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) interpreting clinical meaningfulness of safety and efficacy of SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (LRP) at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP), May 15-17, 2025 in Orlando, FL.
Poster Content: 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. Click here to download the poster.
Authors: Miller AM, Knezevic NN, Nalamachu S, Meske D, Ambrose C, Vought K, Chan EK, and Lissin D.
The poster is on display throughout the meeting from Thursday, May 15 through Saturday, May 17, 2025, allowing all attendees to view it. It is also available via the conference app and will be published in the Pain Physician journal.
Interpretation of the clinical meaningfulness of results requires consideration of primary and secondary endpoints assessed with-in subject based on consensus benchmarks, and the between group differences in the context of the overall risk-benefit and in comparison, to other approved products for similar indications. The results of the CLEAR Trial show clear clinically meaningful separation between SP-102 and placebo in multiple with-in subject endpoints (NPRS Responder Analyses, ODI and BPI Pain Interference). This result is enhanced when solely considering a population that was confirmed to receive study drug by an independent expert (i.e., the mITT population). This trend is also observed in the magnitude of group mean differences, particularly when the standard effect size of SP-102 is compared to other marketed and approved analgesics for chronic low back pain (CLBP), as well as other TSIs. The formulation of SP-102 was intentionally created to offer a safer alternative to current off-label use of products that contain warnings of the potential 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.
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About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system)
In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system)
Scilex Holding Company is headquartered in Palo Alto, California.
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the presentation of post-hoc analysis of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) interpreting clinical meaningfulness of safety and efficacy of SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (LRP).
Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to remain in compliance with the Nasdaq continued listing requirements and to maintain the listing of the Company’s securities thereon; Scilex’s ability to develop and commercialize treatments for obesity, neurodegenerative, and cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.
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Office: (650) 516-4310
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Website: www.scilexholding.com
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.
Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.
ELYXYB® is a registered trademark owned by Scilex Holding Company.
All other trademarks are the property of their respective owners.
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FAQ
What are the key findings of Scilex's (SCLX) CLEAR trial for SP-102?
How does SP-102 compare to existing treatments for lumbosacral radicular pain?
What is the purpose of Scilex's SP-102 (SEMDEXA) drug?
Where did Scilex present their CLEAR trial results for SP-102?
