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
Website:
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.
加利福尼亚州帕洛阿尔托，2023年9月12日（GLOBE NEWSWIRE）——Scilex Holding Company（纳斯达克股票代码：SCLX，“SCLX” 或 “公司”），索伦托治疗公司（场外交易代码：SRNEQ）的多数股权子公司，是一家创新的创收公司，专注于收购、开发和商业化用于治疗急性和非阿片类疼痛管理产品慢性疼痛宣布，它在2023年年度大脑周会议上发表了关于Elyxyb（塞来昔布口服溶液）益处的口头和海报演讲。会议于2023年9月6日至8日在内华达州拉斯维加斯举行。
Elyxyb（塞来昔布口服溶液）演示的主要亮点：
“对Elyxyb和另外两种不同类别的新口服药物，降钙素基因相关肽（CGRP）受体拮抗剂的比较分析清楚地表明，这些优势对于Elyxyb的分化、起病更快和更安全的特征非常重要。Elyxyb是治疗急性偏头痛的军械库的非凡补充。” 美国康涅狄格州斯坦福新英格兰神经病学和头痛研究所医学博士斯图尔特·特珀说。
关于 Scilex 控股公司
Scilex Holding Company是一家创新的创收公司，专注于收购、开发和商业化用于治疗急性和慢性疼痛的非阿片类疼痛管理产品。Scilex毫不妥协地致力于成为全球疼痛管理领导者，致力于遵守社会、环境、经济和道德原则，负责任地开发药品以最大限度地提高生活质量。用于治疗腰骶神经根性疼痛（坐骨神经痛）的新型非阿片类药物SEMDEXATM的III期Pivotal试验C.L.E.A.R. 计划的结果已于2022年3月公布。Scilex参加了C型会议，目的是与美国食品药品管理局进行NDA前讨论，目前正在等待美国食品和药物管理局的书面正式会议记录。Scilex瞄准需求未得到满足且市场机会大的适应症，为中度至重度疼痛患者提供非阿片类药物疗法。Scilex于2018年10月推出了其首款商业产品ztLido，于2022年6月获得了商业产品Gloperba的许可，并于2023年4月推出了其第三款获得美国食品药品管理局批准的产品ElyxybTM。它还在开发其后期产品线，其中包括一个关键的第三阶段候选药以及一个第二阶段和一个第一阶段候选药物。其商业产品ztLido（利多卡因局部治疗系统）1.8％（ztLido）是美国食品药品监督管理局批准的利多卡因外用处方产品，用于缓解与疱疹后神经痛相关的疼痛，这是带状疱疹后神经痛的一种形式。Scilex在美国获得商业化Gloperba（秋水仙碱USP）口服溶液的专有权，这是一种经美国食品药品管理局批准的治疗成人痛风发作的预防性治疗药物。Scilex 在美国和加拿大许可了ElyxybTM（塞来昔布口服溶液）商业化的专有权，这是唯一经美国食品药品管理局批准的用于偏头痛急性治疗的即用型口服溶液，有或不含AI ura，在成人中。Scilex于2023年4月推出了ElyxyBTM，并计划在2023年第四季度将Gloperba商业化，并且完全有能力营销和分销这些产品。Scilex 的三种候选产品是 SP-102（含有 10 mg 地塞米松的注射用地塞米松磷酸钠粘稠凝胶产品）或 SEMDEXA，这是一种广泛用于硬膜外注射的皮质类固醇治疗腰骶神经根疼痛或坐骨神经痛，已获得美国食品药品管理局快速通道认证；SP-103（利多卡因局部用药系统）5.4％，一项2期研究，ztLido的三重强度配方，用于治疗急性腰痛，已获得美国食品药品管理局的快速通道资格；SP-104，4.5 mg 延迟爆发释放低剂量盐酸纳曲酮(DBR-LDN) 胶囊，用于治疗慢性疼痛、纤维肌痛，已完成多个1期试验项目，预计将于2023年启动2期试验。有关 SP-102 3 期疗效试验的更多信息，请参阅 NCT 标识符 NCT03372161 — 治疗神经根病的皮质类固醇腰硬膜外镇痛——全文视图 — ClinicalTrials.gov。
Scilex 控股公司总部位于加利福尼亚州帕洛阿尔托。
前瞻性陈述
根据1995年《私人证券诉讼改革法》第21E条的安全港条款，本新闻稿以及在任何演讲或会议上就本新闻稿所讨论的事项发表的任何声明都包含与Scilex及其子公司相关的前瞻性陈述，并且存在风险和不确定性，可能导致实际结果与预期存在重大差异。前瞻性陈述包括关于Elyxyb可能提供显著治疗益处的陈述，Elyxyb令人鼓舞的疗效、安全性和耐受性，与ubrogepant或rimegepant相比，Elyxyb有可能成为更受欢迎的止痛疗法，Scilex计划在2023年第四季度将Gloperba商业化，Scilex认为自己有能力在未来几年继续增长，Scilex 的长期目标和商业化计划，Scilex吸引新资金的潜力，未来的机会Scilex、Scilex的未来业务战略、Scilex的预期现金资源及其预期用途；Scilex当前和潜在的候选产品、计划中的临床试验和临床前活动以及潜在的产品批准，以及任何获批产品获得市场接受的可能性和相关的市场机会；有关ztLido、Gloperba、ELYXYBTM的声明， SP-102 (SEMDEXA)、SP-103 或 SP-104（如果获得 FDA 批准）；Scilex 的开发和商业化计划；以及 Scilex 的产品、技术和前景。
可能导致Scilex的实际业绩与我们前瞻性陈述中表达的结果存在重大和不利差异的风险和不确定性包括但不限于：先前的测试、研究和试验结果可能无法在持续或未来的研究和试验中复制的风险；与交易市场的不可预测性以及是否会为Scilex的普通股建立市场相关的风险；总体经济、政治和商业状况；与正在进行的 COVID-19 相关的风险大流行；潜在的风险Scilex开发的候选产品可能无法在预期的时间表内或根本无法通过临床开发取得进展或获得所需的监管部门批准；与Scilex候选产品监管途径的不确定性相关的风险；Scilex无法成功上市其候选产品或获得市场接受的风险；Scilex的候选产品可能对患者无益或成功商业化的风险；Scilex高估的风险目标患者群体的规模，他们的尝试新疗法的意愿和医生开这些疗法处方的意愿；SP-103 的 2 期试验或 SP-104 的 1 期试验结果可能不成功的风险；SP-102（SEMDEXA）、SP-103 或 SP-104 的先前临床试验结果可能无法复制的风险；监管和知识产权风险；以及不时显示的其他风险和不确定性以及 Scilex 向证券公司提交的文件中列出的其他风险交易委员会。提醒投资者不要过分依赖这些前瞻性陈述，这些陈述仅代表截至本新闻稿发布之日，除非法律要求，否则Scilex没有义务更新本新闻稿中的任何前瞻性陈述。
联系人：
投资者和媒体
Scilex 控股公司
圣安东尼奥路 960 号
加利福尼亚州帕洛阿尔托 94303
办公室：(650) 516-4310
电子邮件：investorrelations@scilexholding.com
网站：
SEMDEXA（SP-102）是Scilex Holding Company的全资子公司Semnur Pharmicals, Inc. 拥有的商标。美国食品和药物管理局计划对专有名称进行审查。
ztLido是Scilex Holding Company的全资子公司Scilex Pharmicals Inc. 拥有的注册商标。
Gloperba 获得 Scilex Holding Company 独家、可转让的使用注册商标的许可。
ELYXYBTM是Scilex Holding Company使用该商标的独家可转让许可的标的。
所有其他商标均为其各自所有者的财产。
2023 Scilex 控股公司版权所有。
In a post hoc analysis, Elyxyb demonstrated higher pain freedom rates from 60 mins through 3 hours post dose compared to ubrogepant 100 mg and Rimegepant 75 mg. Additionally, Number Needed to Treat (NNT) was lower while Number Needed to Harm (NNH) was higher with Elyxyb than ubrogepant and rimegepant. Taken together, these data suggest that to achieve pain freedom with Elyxyb, fewer patients need to be treated and may have less likelihood of being harmed, than with ubrogepant or rimegepant.
在事后分析中，与ubrogepant 100 mg和Rimegepant 75 mg相比，Elyxyb在给药后60分钟至3小时内表现出更高的疼痛自由率。此外，Elyxyb需要治疗的人数（NNT）较低，而需要伤害的人数（NNH）高于ubrogepant和rimegepant。总而言之，这些数据表明，与ubrogepant或rimegepant相比，使用Elyxyb实现无疼痛感，需要治疗的患者更少，受到伤害的可能性也更小。