PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or "Company"), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual Brain Week Conference on the benefits of Elyxyb (celecoxib oral solution). The conference was held from September 6-8, 2023 in Las Vegas, NV.
Key highlights of Elyxyb (celecoxib oral solution) presentation:
"Comparative analysis of Elyxyb and two other new oral medications of a different class, calcitonin gene-related peptide (CGRP) receptor antagonists, clearly demonstrates advantages that are very important for differentiation of Elyxyb, faster onset and safer profile. Elyxyb is a remarkable addition to armamentarium for treatment of acute migraine." said Stewart Tepper, MD, The New England Institute for Neurology and Headache, Stamford, CT, USA.
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 is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXATM, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and is pending official minutes in writing from the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido in October 2018, in-licensed a commercial product Gloperba in June 2022, and launched its third FDA-approved product ElyxybTM in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido (lidocaine topical system) 1.8%, or ZTlido, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize ElyxybTM (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched ElyxybTM in April 2023, and is planning to commercialize Gloperba in the fourth quarter of 2023, and is well-positioned to market and distribute those products. Scilex's three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2 study, triple-strength formulation of ZTlido, for the treatment of acute low back pain, with FDA Fast Track status; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2023. For further information regarding the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161 – Corticosteroid Lumbar Epidural Analgesia for Radiculopathy – Full Text View – ClinicalTrials.gov.
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 Elyxyb's potential to provide significant treatment benefits, Elyxyb's promising efficacy, safety and tolerability profile, Elyxyb's potential to be a preferable pain treatment compared to ubrogepant or rimegepant, Scilex's plans to commercialize Gloperba in the fourth quarter of 2023, Scilex's belief that it is well positioned to continue its growth over the next several years, Scilex's long-term objectives and commercialization plans, Scilex's potential to attract new capital, future opportunities for Scilex, Scilex's future business strategies, the expected cash resources of Scilex and the expected uses thereof; Scilex's current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido, Gloperba, ELYXYBTM, SP-102 (SEMDEXA), SP-103 or SP-104, if approved by the FDA; Scilex's development and commercialization plans; and Scilex's products, technologies and prospects.
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: the risk that prior test, study and trial results, may not be replicated in continuing or future studies and trials; 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 the ongoing COVID-19 pandemic; 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 results of the Phase 2 trial for SP-103 or Phase 1 trials for SP-104 may not be successful; risks that the prior results of the clinical 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 set forth in Scilex's filings with the Securities and Exchange Commission. 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
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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.
ELYXYBTM is the subject of an exclusive, transferable license to use the trademark by Scilex Holding Company.
All other trademarks are the property of their respective owners.
2023 Scilex Holding Company All Rights Reserved.
加利福尼亞州帕洛阿爾託，2023年9月12日（GLOBE NEWSWIRE）——Scilex Holding Company（納斯達克股票代碼：SCLX，“SCLX” 或 “公司”），索倫託治療公司（場外交易代碼：SRNEQ）的多數股權子公司，是一家創新的創收公司，專注於收購、開發和商業化用於治療急性和非阿片類疼痛管理產品慢性疼痛宣佈，它在2023年年度大腦週會議上發表了關於Elyxyb（塞來昔布口服溶液）益處的口頭和海報演講。會議於2023年9月6日至8日在內華達州拉斯維加斯舉行。
Elyxyb（塞來昔布口服溶液）演示的主要亮點：
“對Elyxyb和另外兩種不同類別的新口服藥物，降鈣素基因相關肽（CGRP）受體拮抗劑的比較分析清楚地表明，這些優勢對於Elyxyb的分化、起病更快和更安全的特徵非常重要。Elyxyb是治療急性偏頭痛的軍械庫的非凡補充。” 美國康涅狄格州斯坦福新英格蘭神經病學和頭痛研究所醫學博士斯圖爾特·特珀說。
關於 Scilex 控股公司
Scilex Holding Company是一家創新的創收公司，專注於收購、開發和商業化用於治療急性和慢性疼痛的非阿片類疼痛管理產品。Scilex毫不妥協地致力於成爲全球疼痛管理領導者，致力於遵守社會、環境、經濟和道德原則，負責任地開發藥品以最大限度地提高生活質量。用於治療腰骶神經根性疼痛（坐骨神經痛）的新型非阿片類藥物SEMDEXATM的III期Pivotal試驗C.L.E.A.R. 計劃的結果已於2022年3月公佈。Scilex參加了C型會議，目的是與美國食品藥品管理局進行NDA前討論，目前正在等待美國食品和藥物管理局的書面正式會議記錄。Scilex瞄準需求未得到滿足且市場機會大的適應症，爲中度至重度疼痛患者提供非阿片類藥物療法。Scilex於2018年10月推出了其首款商業產品ztLido，於2022年6月獲得了商業產品Gloperba的許可，並於2023年4月推出了其第三款獲得美國食品藥品管理局批准的產品ElyxybTM。它還在開發其後期產品線，其中包括一個關鍵的第三階段候選藥以及一個第二階段和一個第一階段候選藥物。其商業產品ztLido（利多卡因局部治療系統）1.8％（ztLido）是美國食品藥品監督管理局批准的利多卡因外用處方產品，用於緩解與皰疹後神經痛相關的疼痛，這是帶狀皰疹後神經痛的一種形式。Scilex在美國獲得商業化Gloperba（秋水仙鹼USP）口服溶液的專有權，這是一種經美國食品藥品管理局批准的治療成人痛風發作的預防性治療藥物。Scilex 在美國和加拿大許可了ElyxybTM（塞來昔布口服溶液）商業化的專有權，這是唯一經美國食品藥品管理局批准的用於偏頭痛急性治療的即用型口服溶液，有或不含AI ura，在成人中。Scilex於2023年4月推出了ElyxyBTM，並計劃在2023年第四季度將Gloperba商業化，並且完全有能力營銷和分銷這些產品。Scilex 的三種候選產品是 SP-102（含有 10 mg 地塞米松的注射用地塞米松磷酸鈉粘稠凝膠產品）或 SEMDEXA，這是一種廣泛用於硬膜外注射的皮質類固醇治療腰骶神經根疼痛或坐骨神經痛，已獲得美國食品藥品管理局快速通道認證；SP-103（利多卡因局部用藥系統）5.4％，一項2期研究，ztLido的三重強度配方，用於治療急性腰痛，已獲得美國食品藥品管理局的快速通道資格；SP-104，4.5 mg 延遲爆發釋放低劑量鹽酸納曲酮(DBR-LDN) 膠囊，用於治療慢性疼痛、纖維肌痛，已完成多個1期試驗項目，預計將於2023年啓動2期試驗。有關 SP-102 3 期療效試驗的更多信息，請參閱 NCT 標識符 NCT03372161 — 治療神經根病的皮質類固醇腰硬膜外鎮痛——全文視圖 — ClinicalTrials.gov。
Scilex 控股公司總部位於加利福尼亞州帕洛阿爾託。
前瞻性陳述
根據1995年《私人證券訴訟改革法》第21E條的安全港條款，本新聞稿以及在任何演講或會議上就本新聞稿所討論的事項發表的任何聲明都包含與Scilex及其子公司相關的前瞻性陳述，並且存在風險和不確定性，可能導致實際結果與預期存在重大差異。前瞻性陳述包括關於Elyxyb可能提供顯著治療益處的陳述，Elyxyb令人鼓舞的療效、安全性和耐受性，與ubrogepant或rimegepant相比，Elyxyb有可能成爲更受歡迎的止痛療法，Scilex計劃在2023年第四季度將Gloperba商業化，Scilex認爲自己有能力在未來幾年繼續增長，Scilex 的長期目標和商業化計劃，Scilex吸引新資金的潛力，未來的機會Scilex、Scilex的未來業務戰略、Scilex的預期現金資源及其預期用途；Scilex當前和潛在的候選產品、計劃中的臨床試驗和臨床前活動以及潛在的產品批准，以及任何獲批產品獲得市場接受的可能性和相關的市場機會；有關ztLido、Gloperba、ELYXYBTM的聲明， SP-102 (SEMDEXA)、SP-103 或 SP-104（如果獲得 FDA 批准）；Scilex 的開發和商業化計劃；以及 Scilex 的產品、技術和前景。
可能導致Scilex的實際業績與我們前瞻性陳述中表達的結果存在重大和不利差異的風險和不確定性包括但不限於：先前的測試、研究和試驗結果可能無法在持續或未來的研究和試驗中複製的風險；與交易市場的不可預測性以及是否會爲Scilex的普通股建立市場相關的風險；總體經濟、政治和商業狀況；與正在進行的 COVID-19 相關的風險大流行；潛在的風險Scilex開發的候選產品可能無法在預期的時間表內或根本無法通過臨床開發取得進展或獲得所需的監管部門批准；與Scilex候選產品監管途徑的不確定性相關的風險；Scilex無法成功上市其候選產品或獲得市場接受的風險；Scilex的候選產品可能對患者無益或成功商業化的風險；Scilex高估的風險目標患者羣體的規模，他們的嘗試新療法的意願和醫生開這些療法處方的意願；SP-103 的 2 期試驗或 SP-104 的 1 期試驗結果可能不成功的風險；SP-102（SEMDEXA）、SP-103 或 SP-104 的先前臨床試驗結果可能無法複製的風險；監管和知識產權風險；以及不時顯示的其他風險和不確定性以及 Scilex 向證券公司提交的文件中列出的其他風險交易委員會。提醒投資者不要過分依賴這些前瞻性陳述，這些陳述僅代表截至本新聞稿發佈之日，除非法律要求，否則Scilex沒有義務更新本新聞稿中的任何前瞻性陳述。
聯繫人：
投資者和媒體
Scilex 控股公司
聖安東尼奧路 960 號
加利福尼亞州帕洛阿爾託 94303
辦公室：(650) 516-4310
電子郵件：investorrelations@scilexholding.com
網站：
SEMDEXA（SP-102）是Scilex Holding Company的全資子公司Semnur Pharmicals, Inc. 擁有的商標。美國食品和藥物管理局計劃對專有名稱進行審查。
ztLido是Scilex Holding Company的全資子公司Scilex Pharmicals Inc. 擁有的註冊商標。
Gloperba 獲得 Scilex Holding Company 獨家、可轉讓的使用註冊商標的許可。
ELYXYBTM是Scilex Holding Company使用該商標的獨家可轉讓許可的標的。
所有其他商標均爲其各自所有者的財產。
2023 Scilex 控股公司版權所有。
