share_log

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宣布 FDA 接受 TNX-102 SL 治疗纤维肌痛的新药申请 (NDA)
美股SEC公告 ·  2024/12/17 07:08

Moomoo AI 已提取核心信息

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宣布FDA已接受其TNX-102 SL新药申请，这是一种用于纤维肌痛管理的非阿片类镇痛剂。FDA预计将在即将发布的第74天信函中分配PDUFA目标行动日期并决定优先审评状态。TNX-102 SL于2024年7月获得快速通道指定。该新药申请得到了两项成功的第三阶段试验的支持，分别是RELIEF和RESILIENt，结果显示与安慰剂相比，疼痛显著减轻。TNX-102 SL一般耐受良好，没有新的安全信号。如果获得批准，它将是15年来首款新型纤维肌痛药物，可能惠及超过1000万受该控件影响的美国成年人。Tonix致力于解决纤维肌痛患者的未满足需求，指出在诊断后18个月，患者更有可能被开处方阿片类药物而非FDA批准的药物。该公司正在推进潜在的2025年上市的商业准备，利用其现有的商业团队支持偏头痛治疗药物Zembrace SymTouch和Tosymra。
Tonix Pharmaceuticals宣布FDA已接受其TNX-102 SL新药申请，这是一种用于纤维肌痛管理的非阿片类镇痛剂。FDA预计将在即将发布的第74天信函中分配PDUFA目标行动日期并决定优先审评状态。TNX-102 SL于2024年7月获得快速通道指定。该新药申请得到了两项成功的第三阶段试验的支持，分别是RELIEF和RESILIENt，结果显示与安慰剂相比，疼痛显著减轻。TNX-102 SL一般耐受良好，没有新的安全信号。如果获得批准，它将是15年来首款新型纤维肌痛药物，可能惠及超过1000万受该控件影响的美国成年人。Tonix致力于解决纤维肌痛患者的未满足需求，指出在诊断后18个月，患者更有可能被开处方阿片类药物而非FDA批准的药物。该公司正在推进潜在的2025年上市的商业准备，利用其现有的商业团队支持偏头痛治疗药物Zembrace SymTouch和Tosymra。
有用
没用

该公告为独立文件：

独立文件1  查看翻译

独立文件2  查看翻译

声明：本内容仅用作提供资讯及教育之目的，不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    热议
    美股
    股票代码最新价涨跌幅

    暂无数据

    资讯热榜
    更新时间