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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia

Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia

Tonix Pharmaceuticals | 8-K：Tonix Pharmaceuticals宣佈 FDA 接受 TNX-102 SL 治療纖維肌痛的新藥申請 (NDA)
美股SEC公告 ·  2024/12/17 08:08

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Tonix Pharmaceuticals announced FDA acceptance of its New Drug Application for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The FDA is expected to assign a PDUFA target action date and decide on Priority Review status in the upcoming Day 74 Letter. TNX-102 SL received Fast Track designation in July 2024.The NDA is supported by two successful Phase 3 trials, RELIEF and RESILIENT, which demonstrated significant pain reduction compared to placebo. TNX-102 SL was generally well-tolerated with no new safety signals. If approved, it would be the first new fibromyalgia drug in over 15 years, potentially benefiting over 10 million U.S. adults affected by the condition.Tonix aims to address the unmet needs of fibromyalgia patients, noting that 18 months post-diagnosis, patients are more likely prescribed opioids than FDA-approved drugs. The company is advancing commercial preparations for a potential 2025 launch, leveraging its existing commercial team supporting migraine treatments Zembrace SymTouch and Tosymra.
Tonix Pharmaceuticals announced FDA acceptance of its New Drug Application for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The FDA is expected to assign a PDUFA target action date and decide on Priority Review status in the upcoming Day 74 Letter. TNX-102 SL received Fast Track designation in July 2024.The NDA is supported by two successful Phase 3 trials, RELIEF and RESILIENT, which demonstrated significant pain reduction compared to placebo. TNX-102 SL was generally well-tolerated with no new safety signals. If approved, it would be the first new fibromyalgia drug in over 15 years, potentially benefiting over 10 million U.S. adults affected by the condition.Tonix aims to address the unmet needs of fibromyalgia patients, noting that 18 months post-diagnosis, patients are more likely prescribed opioids than FDA-approved drugs. The company is advancing commercial preparations for a potential 2025 launch, leveraging its existing commercial team supporting migraine treatments Zembrace SymTouch and Tosymra.
Tonix Pharmaceuticals宣佈FDA已接受其TNX-102 SL新藥申請，這是一種用於纖維肌痛管理的非阿片類鎮痛劑。FDA預計將在即將發佈的第74天信函中分配PDUFA目標行動日期並決定優先審評狀態。TNX-102 SL於2024年7月獲得快速通道指定。該新藥申請得到了兩項成功的第三階段試驗的支持，分別是RELIEF和RESILIENt，結果顯示與安慰劑相比，疼痛顯著減輕。TNX-102 SL一般耐受良好，沒有新的安全信號。如果獲得批准，它將是15年來首款新型纖維肌痛藥物，可能惠及超過1000萬受該控件影響的美國成年人。Tonix致力於解決纖維肌痛患者的未滿足需求，指出在診斷後18個月，患者更有可能被開處方阿片類藥物而非FDA批准的藥物。該公司正在推進潛在的2025年上市的商業準備，利用其現有的商業團隊支持偏頭痛治療藥物Zembrace SymTouch和Tosymra。
Tonix Pharmaceuticals宣佈FDA已接受其TNX-102 SL新藥申請，這是一種用於纖維肌痛管理的非阿片類鎮痛劑。FDA預計將在即將發佈的第74天信函中分配PDUFA目標行動日期並決定優先審評狀態。TNX-102 SL於2024年7月獲得快速通道指定。該新藥申請得到了兩項成功的第三階段試驗的支持，分別是RELIEF和RESILIENt，結果顯示與安慰劑相比，疼痛顯著減輕。TNX-102 SL一般耐受良好，沒有新的安全信號。如果獲得批准，它將是15年來首款新型纖維肌痛藥物，可能惠及超過1000萬受該控件影響的美國成年人。Tonix致力於解決纖維肌痛患者的未滿足需求，指出在診斷後18個月，患者更有可能被開處方阿片類藥物而非FDA批准的藥物。該公司正在推進潛在的2025年上市的商業準備，利用其現有的商業團隊支持偏頭痛治療藥物Zembrace SymTouch和Tosymra。
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