Scilex Holding Announces Publication Of Trial Results For SP-102 (SEMDEXA) In PAIN Journal; Focuses On Non-Opioid Pain Management Products For Acute And Chronic Pain
Scilex Holding Announces Publication Of Trial Results For SP-102 (SEMDEXA) In PAIN Journal; Focuses On Non-Opioid Pain Management Products For Acute And Chronic Pain
Scilex Holding宣佈《PAIN雜誌》發表SP-102(SEMDEXA)試驗結果;重點關注急性和慢性疼痛的非阿片類疼痛管理產品
- 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. 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.
- SP-102 (SEMDEXA) was granted Fast Track status from the FDA in 2017.
- 第三階段研究結果已被髮表在PAIN雜誌上，該雜誌是專門致力於疼痛醫學和研究的領先雜誌。PAIN是國際疼痛研究協會的官方雜誌，涵蓋了有關疼痛性質、機制和治療的原始研究。
- 通過使用SP-102（SEMDEXA）治療，這項第三階段研究滿足了主要和重要的關鍵次要終點，並減少了坐骨神經痛患者一個月以上的疼痛強度，同時在維持與安慰劑相當的安全性的同時，導致殘疾指數得分的統計顯着和臨床意義的改善。
- SP-102（SEMDEXA）的第三階段最終數據結果在2022年5月的美國介入性疼痛學會議上由伊利諾伊大學芝加哥校區醫學院麻醉學和外科學教授、伊利諾伊州介入性疼痛醫師協會主席、北美神經調節學會大陸主席、Adovcate Illinois免疫醫學中心疼痛管理科研和教育副主席的Nebojsa Nick Knezevic博士發表口頭演講。
- SP-102（SEMDEXA）在2017年獲得FDA的快速通道狀態。
譯文內容由第三人軟體翻譯。
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