Scilex Holding Company Provides Responses To Product Composition Questions Related To Its ELYXYB Patent In Canada For A New Drug Submission Under Review By Health Canada
Scilex Holding Company Provides Responses To Product Composition Questions Related To Its ELYXYB Patent In Canada For A New Drug Submission Under Review By Health Canada
- ELYXYB is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1
- According to market data from 2018, it was found that migraine was more severe than other types of headaches and it impacted more than 2.7 million Canadians with the Canadian migraine therapeutics market estimated to reach approximately $400 million by 2025.2
- There is strong evidence for the use of non-steroidal anti-inflammatory drugs (NSAIDs) as a first-line treatment for migraine. ELYXYB (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3
- The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and information requests by Health Canada. Scilex filed the NDS with Health Canada's Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences in December 2023
- ELYXYB 是一線療法，也是唯一獲得 FDA 批准的即用型口服溶液，用於急性治療成人偏頭痛，無論有無先兆。1
- 根據2018年的市場數據，發現偏頭痛比其他類型的頭痛更爲嚴重，它影響了超過270萬加拿大人，到2025年，加拿大的偏頭痛治療市場估計將達到約4億加元。2
- 有強有力的證據表明使用非甾體抗炎藥（NSAID）作爲偏頭痛的一線治療方法。ELYXYB（塞來昔布口服溶液）屬於同一類藥物，起效快，並且有可能在所有非甾體抗炎藥中具有最低的胃腸道（GI）副作用。3
- 加拿大的預期批准期限約爲12個月，具體取決於審查週期和加拿大衛生部的信息請求。Scilex 於 2023 年 12 月向加拿大衛生部藥物管理局、心臟病學、過敏和神經科學局提交了國家安全數據表
PALO ALTO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (NASDAQ:SCLX, " Scilex" or " Company" ))))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has responded to questions on the product composition in the ELYXYB patent from Health Canada's Office of Patented Medicines and Liaison (OPML) during review of a New Drug Submission ("NDS") to Health Canada's Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of ELYXYB for acute treatment of migraine with or without aura in Canada.
加利福尼亞州帕洛阿爾託，2024年3月18日（GLOBE NEWSWIRE）——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的創新創收公司Scilex控股公司（納斯達克股票代碼：SCLX，“Scilex” 或 “公司”）））今天宣佈，它已回答有關ELYX產品組成的問題加拿大衛生部專利藥物和聯絡辦公室（OPML）在審查向加拿大衛生部藥品局提交的新藥（“NDS”）時獲得的YB專利，加拿大心臟病學、過敏和神經科學局批准ELYXYB用於急性治療有或沒有先兆的偏頭痛。
Clinicians in a recent market research study expressed their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy and those who have contraindications to triptan use. ELYXYB's product profile mapped with a high degree of certainty to these stated unmet needs. In clinical studies, patients treated with ELYXYB demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in approximately 50% of patients.4,5
在最近的一項市場研究中，臨床醫生表示，他們希望爲兩大批急性偏頭痛患者——對曲坦療法反應不足的患者和對曲坦使用禁忌症的患者——尋求快速安全的替代方案。ELYXYB的產品概況可以高度確定地映射到這些未滿足的既定需求。在臨床研究中，接受ELYXYB治療的患者在短短15分鐘內表現出緩解疼痛，與安慰劑相比，約有50％的患者在45分鐘內顯著緩解疼痛。4,5
譯文內容由第三人軟體翻譯。