Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company, Announces Successful End of Phase II Meeting with FDA Leading to an Agreed Path Forward to NDA Upon Completion of Phase III Trials for Blockbuster Product Candidate, SP-103 (Lidocaine Topical System) 5.4%, a Next-Generation, Triple-Strength Formulation of ZTlido, for the Treatment of Chronic Neck Pain Associated with Muscle Spasms
Scilex Holding Company (SCLX) announced a successful end of Phase II meeting with FDA for SP-103, a triple-strength formulation of ZTlido for chronic neck pain treatment. The FDA provided a clear path to NDA following Phase III trials completion. SP-103, a lidocaine topical system 5.4%, targets the U.S. low back and neck pain market, projected to reach $134.5 billion. According to Syneos Health Consulting research, SP-103's peak sales potential is estimated at $1.2 billion annually by the 6th year post-launch. The company currently has three FDA-approved commercial products: ZTlido, ELYXYB, and Gloperba.
Scilex Holding Company (SCLX) ha annunciato una conclusione positiva dell'incontro di Fase II con la FDA riguardo a SP-103, una formulazione a tripla potenza di ZTlido per il trattamento del dolore cronico al collo. La FDA ha fornito un percorso chiaro per la NDA dopo il completamento degli studi di Fase III. SP-103, un sistema topico di lidocaina al 5,4%, mira al mercato del dolore lombare e cervicale negli Stati Uniti, che si prevede raggiunga i 134,5 miliardi di dollari. Secondo la ricerca di Syneos Health Consulting, il potenziale di vendita massima di SP-103 è stimato in 1,2 miliardi di dollari all'anno entro il sesto anno dopo il lancio. Attualmente, l'azienda dispone di tre prodotti commerciali approvati dalla FDA: ZTlido, ELYXYB e Gloperba.
Scilex Holding Company (SCLX) anunció el exitoso cierre de la reunión de Fase II con la FDA para SP-103, una formulación de triple potencia de ZTlido para el tratamiento del dolor crónico en el cuello. La FDA proporcionó un camino claro hacia la NDA tras la finalización de los ensayos de Fase III. SP-103, un sistema tópico de lidocaína al 5,4%, se dirige al mercado del dolor lumbar y cervical en EE. UU., que se proyecta alcanzará los 134,5 mil millones de dólares. Según la investigación de Syneos Health Consulting, el potencial de ventas máximas de SP-103 se estima en 1.2 mil millones de dólares anuales para el sexto año después de su lanzamiento. La compañía cuenta actualmente con tres productos comerciales aprobados por la FDA: ZTlido, ELYXYB y Gloperba.
Scilex Holding Company (SCLX)는 만성 목 통증 치료를 위한 ZTlido의 삼중 강도 제형인 SP-103에 대한 FDA와의 2상 회의 성공적 종료를 발표했습니다. FDA는 3상 시험 완료 후 NDA로 가는 명확한 경로를 제공했습니다. SP-103은 5.4%의 리도카인 경피 시스템으로, 미국의 허리 및 목 통증 시장을 목표로 하며, 이 시장은 1,345억 달러에 이를 것으로 예상됩니다. Syneos Health Consulting의 연구에 따르면, SP-103의 최대 판매 잠재력은 출시 후 6년 이내에 연간 12억 달러로 추정됩니다. 현재 이 회사는 FDA에서 승인한 3개의 상업용 제품인 ZTlido, ELYXYB 및 Gloperba를 보유하고 있습니다.
Scilex Holding Company (SCLX) a annoncé la fin réussie de la réunion de Phase II avec la FDA pour SP-103, une formulation à triple puissance de ZTlido pour le traitement de la douleur chronique au cou. La FDA a fourni un chemin clair vers la NDA après l'achèvement des essais de Phase III. SP-103, un système topique de lidocaïne à 5,4 %, cible le marché de la douleur lombaire et cervicale aux États-Unis, qui devrait atteindre 134,5 milliards de dollars. Selon une étude de Syneos Health Consulting, le potentiel de ventes maximales de SP-103 est estimé à 1,2 milliard de dollars par an d'ici la sixième année après son lancement. L'entreprise dispose actuellement de trois produits commerciaux approuvés par la FDA : ZTlido, ELYXYB et Gloperba.
Scilex Holding Company (SCLX) gab bekannt, dass das Treffen der Phase II mit der FDA für SP-103, eine dreifache Stärkeformulierung von ZTlido zur Behandlung von chronischen Nackenschmerzen, erfolgreich abgeschlossen wurde. Die FDA hat nach Abschluss der Phase-III-Studien einen klaren Weg zur NDA aufgezeigt. SP-103, ein topisches Lidocainsystem mit 5,4%, zielt auf den amerikanischen Markt für Schmerzen im unteren Rücken und Nacken ab, der voraussichtlich 134,5 Milliarden Dollar erreichen wird. Laut einer Forschung von Syneos Health Consulting wird das Spitzenverkaufs-Potenzial von SP-103 geschätzt auf 1,2 Milliarden Dollar jährlich im sechsten Jahr nach der Markteinführung. Das Unternehmen hat derzeit drei von der FDA genehmigte kommerzielle Produkte: ZTlido, ELYXYB und Gloperba.
- FDA provided clear path to NDA for SP-103 after Phase II meeting
- SP-103 projected peak sales of $1.2B annually by year 6 post-launch
- ZTlido shows 50% average growth in gross sales over past two years
- ZTlido secured $105M minimum 5-year purchase commitment for international distribution
- Phase III trials still required before NDA submission
- SP-103 revenue potential dependent on successful trial completion and market penetration
Insights
The successful FDA End-of-Phase II meeting for SP-103 marks a significant milestone in Scilex's pain management pipeline. The triple-strength lidocaine formulation (5.4%) demonstrates technological superiority over existing topical treatments, addressing a substantial market need in chronic neck pain treatment. The
The company's existing portfolio of FDA-approved products, including ZTlido®, ELYXYB® and Gloperba®, provides a strong foundation and established commercialization infrastructure. The
This development significantly strengthens Scilex's market position in the non-opioid pain management sector. The
The potential spinoff or public listing of Scilex Pharmaceuticals Inc. could unlock additional shareholder value. The market's positive reception to the FDA meeting outcome could catalyze near-term stock appreciation, particularly given the company's relatively modest market cap of
- Successful end of Phase II meeting with FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103, for the treatment of chronic neck pain associated with muscle spasms.
- SP-103 (lidocaine topical system)
5.4% , (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain. It is estimated that the U.S. low back and neck pain market will reach$134.5 billion .6 Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the substantial intent in utilization for SP-103 with peak sales potential projected to reach$1.2 billion annually in the 6th year post launch. - As previously announced that Scilex Holding Company’s Board of Directors has authorized management to explore ways to maximize the value of Scilex Holding Company and its wholly owned subsidiary, Scilex Pharmaceuticals Inc., including by way of conducting a spinoff or public listing of securities of Scilex Pharmaceuticals Inc.
PALO ALTO, Calif., Oct. 30, 2024 (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, today announced it had a successful end of Phase II meeting with the FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103 (lidocaine topical system)
Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the substantial intent in utilization for SP-103 with peak sales potential projected to reach
"We are very pleased with the end of Phase II meeting and received a clear path forward to NDA for our blockbuster product candidate, SP-103. SP-103 has the potential to meet our core goal of developing leading pain management therapies to significantly improve the lives of patients for the treatment of chronic neck pain associated with muscle spasms who are seeking new effective treatments. We are looking forward to conducting Phase 3 trials and believe that Scilex is the only company with technology allowing much higher lidocaine concentration than any other topical lidocaine system treatments. Higher concentration of a drug per covered area of skin is important for achieving therapeutic response”, said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.
- Scilex Pharmaceuticals, Inc. has three FDA-approved commercial products on the market and 3X version follow-on product, SP-103, is the next generation of ZTlido®:
- ZTlido® (lidocaine topical system)
1.8% , a prescription lidocaine topical product for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain with an average of50% growth in gross sales for the past two years. ZTlido® is expected to be distributed outside of the U.S. in 2025 with exclusive territory distributors in the Middle East and North/South Africa countries with a$105 million minimum 5 year purchase commitment. - ELYXYB® is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1 The U.S. oral migraine drug market size was estimated to be
$1.8 billion in 2022.2 - ELYXYB® filed a New Drug Submission (NDS) to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of for acute treatment of migraine with or without aura in Canada. It is estimated to have impacted more than 2.7 million Canadians with the Canadian migraine therapeutics market estimated to reach approximately
$400 million by 2025.3 - Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States4. The gout treatment market is projected to reach
$2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.5
- ZTlido® (lidocaine topical system)
For more information on Scilex Holding Company, refer to www.scilexholding.com.
For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability.
For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.
For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.
For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.
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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. 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 are 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 Scilex’s development of SP103, the Company’s outlook, goals and expectations for 2024 and 2025, and the Company’s development and commercialization plans.
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: risks associated with the unpredictability of trading markets; general economic, political and business conditions; 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 SEC, including Scilex’s Annual Reports on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, 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.
Contacts:
Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
References
1) Source: Celecoxib Oral Solution Approved for Acute Migraine March 2020.
https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migraine
2) Source: Evaluate Pharma data February 16, 2023
3) Source: Mordor Intelligence - MIGRAINE THERAPEUTICS MARKET (2020-2025)
4) https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%
5) Evaluate Pharma data
6) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725362/#:~:text=Neck%20pain%20is%20a%20multifactorial,
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 Scilex Holding Company to use the registered trademark.
ELYXYB® is a registered trademark owned by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2024 Scilex Holding Company All Rights Reserved.
FAQ
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