Scilex Holding Company Announces Seeking Approval From the FDA for Modification of the Gloperba Label to Provide Specific Dosing Guidance for Patients With Renal Impairment and Other Circumstances Where Dose Adjustment Is Needed
Scilex Holding Company Announces Seeking Approval From the FDA for Modification of the Gloperba Label to Provide Specific Dosing Guidance for Patients With Renal Impairment and Other Circumstances Where Dose Adjustment Is Needed
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Seek approval from the FDA for the modification of the Gloperba label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:
Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
Gloperba is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. According to data gathered by Evaluate Pharma, the gout treatment market is projected to reach $2.0 billion in the United States by 2028 with a well-defined area of unmet need.2
Over 70% of gout patients have comorbid conditions that may require dose adjustments and such patients could be potential target population for Gloperba3
Over 17% of gout patients on colchicine have experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by Gloperba4
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尋求美國食品藥品管理局批准，修改Gloperba標籤，使其能夠利用液體配方的劑量靈活性來滿足未滿足的醫療需求，併爲腎功能損害患者提供具體的劑量指導，如下所述：
應考慮調整劑量爲輕度或中度腎臟或肝臟受損的患者。
對於嚴重腎功能不全的患者，起始劑量應爲0.3 mg/天。
對於接受透析的患者，總推薦劑量應爲0.3 mg，每週給藥兩次。
Gloperba是抗痛風藥物秋水仙鹼的第一個也是唯一的液體口服版本，用於預防成人痛風發作。
痛風是一種痛苦的關節炎疾病，在美國估計有920萬人受到影響1。隨着痛風病例的逐年增加，治療需求也隨之增加。根據Evaluate Pharma收集的數據，預計到2028年，美國的痛風治療市場將達到20億美元，其中有明確的未滿足需求領域。2
超過70％的痛風患者患有合併症，可能需要調整劑量，這些患者可能成爲Gloperba3的潛在目標人群
服用秋水仙鹼的痛風患者中有17％以上出現了嚴重的胃腸道副作用，例如腹瀉。這些患者可能會受益於Gloperba4提供的靈活劑量
PALO ALTO, Calif., March 20, 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 it will seek approval from the FDA for the modification of the Gloperba label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:
加利福尼亞州帕洛阿爾託，2024年3月20日（GLOBE NEWSWIRE）——專注於收購、開發和商業化用於治療急慢性疼痛的非阿片類疼痛管理產品的創新型創收公司Scilex控股公司（納斯達克股票代碼：SCLX，“Scilex” 或 “公司”）今天宣佈，將尋求美國食品藥品管理局批准修改Gloperba標籤，以納入其Gloperba標籤能夠利用液體配方的劑量靈活性來滿足未滿足的醫療需求，並按設定爲腎功能損害患者提供特定的劑量指導在下面：
Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
應考慮調整劑量爲輕度或中度腎臟或肝臟受損的患者。
對於嚴重腎功能不全的患者，起始劑量應爲0.3 mg/天。
對於接受透析的患者，總推薦劑量應爲0.3 mg，每週給藥兩次。
A recent market research study among rheumatologists revealed a high degree of interest in Gloperba as a liquid colchicine formulation designed for precision dosing.5 Specifically, clinicians using colchicine for prophylaxis of gout flares in adults indicated a strong likelihood to use Gloperba instead of tablets/capsules in certain at-risk patient populations who have a clinical need for lowered precision dosing to mitigate the risk of colchicine toxicity. Notably, the American College of Rheumatology (ACR) guidelines also reflect this need.6
風溼病學家最近進行的一項市場研究顯示，Gloperba是一種專爲精確給藥而設計的液態秋水仙鹼配方，引起了極大的興趣。5具體而言，使用秋水仙鹼預防成人痛風發作的臨床醫生表示，對於某些臨床上需要降低精確劑量以降低秋水仙鹼毒性風險的高危患者群體，使用Gloperba代替片劑/膠囊的可能性很大。值得注意的是，美國風溼病學會（ACR）的指南也反映了這種需求。6
Scilex expects to launch Gloperba in the first half of 2024. Gloperba is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Approximately 70% of gout patients have chronic kidney disease stage 2 and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule3. Gloperba is the first and only liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in these at-risk patient populations, and thereby help mitigate against severe toxicity in patients. Healthcare providers can now safely and effectively manage these patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis. For patients who are treated at doses lower than 0.6 mg, the 150 ml bottle of Gloperba is expected to last longer than 30 days, delivering additional value to patients.
Scilex預計將在2024年上半年推出Gloperba。Gloperba 是抗痛風藥物秋水仙鹼的第一個也是唯一的液體口服版本，用於預防成人痛風發作。大約70％的痛風患者患有2期慢性腎臟疾病，許多人患有胃腸道敏感性，因此需要的秋水仙鹼的劑量低於標準的0.6 mg片劑或膠囊3。Gloperba 是第一款也是唯一一款液態秋水仙鹼配方，它允許醫療保健提供者爲這些高危患者群體開出精確劑量的處方，從而幫助減輕患者的嚴重毒性。醫療保健提供者現在可以安全有效地管理這些患者，劑量低於0.6 mg，每天一兩次，這是預防的標準劑量。對於劑量低於0.6 mg的患者，150毫升的Gloperba瓶裝的使用壽命預計將超過30天，從而爲患者帶來額外的價值。
譯文內容由第三人軟體翻譯。