文章核心观点 - 公司宣布在同行评审期刊上发表关于GLOPERBA剂量调整的文章，为痛风和慢性肾衰竭患者的秋水仙碱临床给药提供数据 [1] 公司概况 - 公司是创新型盈利公司，专注获取、开发和商业化非阿片类疼痛管理产品，用于治疗急慢性疼痛、神经退行性和心脏代谢疾病 [1][6] - 公司总部位于加利福尼亚州帕洛阿尔托 [9] 公司产品 商业产品 - ZTlido 1.8%是处方利多卡因外用产品，获美国FDA批准用于缓解带状疱疹后神经痛相关的神经性疼痛 [6] - ELYXYB是潜在一线治疗药物，也是唯一获FDA批准的即用型口服溶液，用于成人偏头痛急性治疗 [6] - Gloperba是首款也是唯一的液体口服抗痛风药物秋水仙碱，用于成人痛风发作的预防，可精准给药并减少严重肾功能损害患者的日剂量，目前在美国生产 [2][6] 产品候选 - SP - 102（SEMDEXA或SP - 102）是新型粘性凝胶制剂，用于硬膜外注射治疗腰骶神经根性疼痛或坐骨神经痛，已完成3期研究，2017年获FDA快速通道资格 [7][8] - SP - 103（5.4%利多卡因外用系统）是ZTlido的下一代三倍强度配方，用于治疗急性疼痛，近期完成急性下腰痛2期试验，在治疗下腰痛方面获FDA快速通道资格 [8] - SP - 104（4.5mg低剂量盐酸纳曲酮缓释胶囊）是新型低剂量缓释盐酸纳曲酮，正在开发用于治疗纤维肌痛 [8] 子公司情况 - Semnur是公司全资子公司，是临床后期专业制药公司，专注开发和商业化新型非阿片类疼痛疗法，其候选产品SP - 102是首个用于硬膜外给药的非阿片类新型凝胶制剂，用于中重度慢性神经根性疼痛/坐骨神经痛患者 [10] - Semnur总部位于加利福尼亚州帕洛阿尔托 [11] 产品优势 - 超70%痛风患者有合并症可能需调整剂量，服用秋水仙碱标准预防剂量的痛风发作患者，若存在肾功能损害或药物相互作用，发生毒性风险增加，指南建议谨慎并由临床医生酌情调整剂量 [2][3] - 药代动力学模型数据分析表明，大多数服用秋水仙碱固体剂型的肾功能损害患者血药浓度会低于或高于治疗水平，易出现潜在副作用，而中度肾功能损害患者服用0.48mg（4mL）秋水仙碱口服溶液、重度肾功能损害患者服用0.3mg（2.5mL），血药浓度在治疗窗内达到最佳水平且安全性更高 [4] 专家评价 - 纽约大学临床与转化科学研究所的Michael H. Pillinger医学博士表示，该重要出版物将为痛风和慢性肾衰竭患者的秋水仙碱临床给药提供急需的数据 [5] 信息链接 - 文章链接：https://link.springer.com/article/10.1007/s40744 - 025 - 00772 - 8 [5] - 公司信息：www.scilexholding.com [5][6] - Semnur信息：www.semnurpharma.com [5] - ZTlido信息：www.ztlido.com [5] - ELYXYB信息：www.elyxyb.com [6] - Gloperba信息：www.gloperba.com [6] - 公司社交媒体：https://www.facebook.com/scilex.pharm、https://www.linkedin.com/company/scilex - holding - company/ [6] - 公司邮箱：info@scilexholding.com [6] 联系方式 - 投资者和媒体联系信息：地址为加利福尼亚州帕洛阿尔托市圣安东尼奥路960号，电话(650) 516 - 4310，邮箱investorrelations@scilexholding.com [13] - 公司网站：www.scilexholding.com [14] 商标信息 - SEMDEXA™（SP - 102）商标归Semnur所有，FDA计划进行专有名称审查 [14] - ZTlido是Scilex Pharmaceuticals Inc.的注册商标 [14] - Gloperba是Scilex获独家可转让许可使用的注册商标 [14] - ELYXYB是公司的注册商标 [15]

Table of Contents As filed with the U.S. Securities and Exchange Commission on November 20, 2023 Registration No. 333-275117 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on November 6, 2023 Registration No. 333-275117 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. E ...

Registration No. As filed with the U.S. Securities and Exchange Commission on October 20, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Scilex Holding Co ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on July 19, 2023 Registration No. 333-271401 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 6 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. Empl ...

As filed with the U.S. Securities and Exchange Commission on July 12, 2023 Registration No. 333-271401 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 5 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificatio ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on June 29, 2023 Registration No. 333-271401 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 4 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. Empl ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on June 16, 2023 (Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices) Jaisim Shah Chief Executive Officer & President 960 San Antonio Road Palo Alto, CA 94303 (650) 516-4310 Registration No. 333-271401 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holdin ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on June 5, 2023 Registration No. 333-271401 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. Emplo ...

Registration No. 333-271401 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Table of Contents As filed with the U.S. Securities and Exchange Commission on May 22, 2023 Amendment No. 1 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scilex Holding Company (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 92-1062542 (Primary Standard Industrial Classification Code Number) (I.R.S. Emplo ...