Scilex Holding Announces FDA Final Approval To Precision Dosing For GLOPERBA Label
Scilex Holding Announces FDA Final Approval To Precision Dosing For GLOPERBA Label
Scilex Holding宣佈FDA最終批准GLOPERBA標籤的精確劑量
- FDA Final Approval to Precision Dosing for GLOPERBA Label.
- We believe 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 U.S. 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 are a potential target population for GLOPERBA.3
- Over 17% of gout patients on colchicine experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by GLOPERBA.4
- Unlike other colchicine formulations, GLOPERBA allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day).
- FDA對GLOPERBA標籤的精確劑量批准最終通過。
- 我們相信GLOPERBA是抗痛風藥物秋水仙鹼的首個唯一的口服液體版本，適用於成人預防痛風性關節炎的發作。
- 痛風是一種疼痛的關節炎性疾病，影響着估計有920萬人口的美國人。隨着痛風病例每年的增加，治療需求也在增加。根據Evaluate Pharma收集的數據，到2028年，美國的痛風治療市場預計將達到20億美元，並存在明確的未滿足需求領域。
- 超過70%的痛風患者存在可能需要劑量調整的合併症，這些患者是GLOPERBA的潛在目標人群。
- 17%以上使用秋水仙鹼的痛風患者會出現嚴重的胃腸道副作用，如腹瀉。這些患者可能會從GLOPERBA提供的靈活劑量中受益。
- 與其他秋水仙鹼製劑不同，GLOPERBA允許在嚴重腎功能損傷的患者中減少每日劑量（0.3毫克/天）。
PALO ALTO, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (NASDAQ:SCLX, "Scilex" or the "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 FDA approval of a Supplemental New Drug Application for Label Updates to GLOPERBA.
加利福尼亞州帕洛阿爾託，2024年8月29日（全球記者報道）-Scilex控股公司（NASDAQ:SCLX，「Scilex」或「公司」），一家專注於收購、開發和銷售非阿片類疼痛管理產品用於急性和慢性疼痛治療的創新型收入公司，今天宣佈 FDA 批准了 GLOPERBA 標籤更新的藥物補充新藥申請。
譯文內容由第三人軟體翻譯。
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