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The Phase 3 study results are being published in PAIN® Journal, which is the leading journal devoted to pain medicine and research. PAIN is the official journal of the International Association for the Study of Pain, and features original research on the nature, mechanisms and treatment of pain.This Phase 3 study met primary and important key secondary endpoints, with SP-102 (SEMDEXA™) treatment, decreasing pain intensity for over a month in sciatica patients and resulting in statistically significant and clinically meaningful improvement in the disability index score while maintaining safety comparable to placebo.This Phase 3 topline data result was presented at the American Society of Interventional Pain (ASIPP) conference in Las Vegas in May 2022 in an oral presentation by Dr.
第三阶段的研究结果发表在疼痛杂志上,该杂志是致力于疼痛医学和研究的领先杂志。疼痛是国际疼痛研究协会的官方杂志,其特点是关于疼痛的性质,机制和治疗的原始研究。这项3期研究符合主要和重要的次要终点,采用SP-102(SEMDEXA TM)治疗,坐骨神经痛患者的疼痛强度降低了一个多月,导致残疾指数评分有统计学意义和临床意义的改善,同时保持与安慰剂相当的安全性。2022年5月,在拉斯维加斯举行的美国介入性疼痛学会(ASIPP)会议上,Dr。
Nebojsa Nick Knezevic, M.D., Ph.D., Professor of Anesthesiology and Surgery, College of Medicine, University of Illinois at Chicago, President of the Illinois Society of Interventional Pain Physicians, Director-at-Large of the North American Society of Neuromodulation, Vice-Chair for Research and Education, Advocate Illinois Masonic Medical Center, Department of Anesthesiology and Pain Management.This Phase 3 study represents a potential significant improvement in treatment of adult patients with lumbosacral radicular pain (sciatica), who struggle with the clinical consequences of no currently FDA approved therapies, suboptimal formulations of corticosteroids used off-label and/or excess pain and disability.SP-102 (SEMDEXA™) was granted Fast Track status from the FDA in 2017.
内博伊萨·尼克·克内泽维奇(NebojsaNickKnezevic),医学博士,博士,伊利诺伊大学芝加哥分校医学院麻醉学和外科教授,伊利诺伊州介入性疼痛医师协会主席,北美神经调节学会理事,研究和教育副主席,伊利诺伊州共济会医学中心麻醉学和疼痛管理系倡导者。这项3期研究代表了成年腰骶神经根性疼痛(坐骨神经痛)患者治疗的潜在显着改善,这些患者正在与目前没有FDA批准的疗法,使用标签外的皮质类固醇的次优制剂和/或过度疼痛和残疾的临床后果作斗争。2017年,SP-102(SEMDEXA™)被FDA授予快速通道状态。
PALO ALTO, Calif., June 14, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opi.
加利福尼亚州帕洛阿尔托,2024年6月14日(环球通讯社)--Scilex控股公司(纳斯达克:SCLX,“Scilex”或“公司”),一家专注于收购、开发和商业化非opi的创新创收公司。