牛牛AI助理已提取核心訊息
On March 6, 2024, Tonix Pharmaceuticals Holding Corp. announced a partnership with EVERSANA Life Science Services, LLC to support the launch and commercial planning of Tonmya™, a product candidate for the management of fibromyalgia in the U.S. Tonix plans to submit a New Drug Application for Tonmya to the FDA in the second half of 2024, following statistically significant results from two Phase 3 trials. The company has also scheduled a Type B pre-NDA meeting with the FDA for the second quarter of 2024. Tonmya, also known as TNX-102 SL, is a non-opioid, centrally acting analgesic that has shown significant pain reduction and improvement in sleep quality, fatigue, and overall fibromyalgia symptoms in clinical trials.
On March 6, 2024, Tonix Pharmaceuticals Holding Corp. announced a partnership with EVERSANA Life Science Services, LLC to support the launch and commercial planning of Tonmya™, a product candidate for the management of fibromyalgia in the U.S. Tonix plans to submit a New Drug Application for Tonmya to the FDA in the second half of 2024, following statistically significant results from two Phase 3 trials. The company has also scheduled a Type B pre-NDA meeting with the FDA for the second quarter of 2024. Tonmya, also known as TNX-102 SL, is a non-opioid, centrally acting analgesic that has shown significant pain reduction and improvement in sleep quality, fatigue, and overall fibromyalgia symptoms in clinical trials.
2024年3月6日，Tonix Pharmicals Holding Corp. 宣佈與EVERSANA Life Science Services, LLC建立合作伙伴關係，以支持美國纖維肌痛管理候選產品Tonmya™ 的推出和商業規劃。Tonix計劃在2024年下半年向美國食品藥品管理局提交Tonmya的新藥申請，此前兩項3期試驗取得了具有統計意義的結果。該公司還計劃在2024年第二季度與美國食品藥品管理局舉行B型保密協議前會議。Tonmya，也被稱爲 TNX-102 SL，是一種非阿片類中樞作用的鎮痛藥，在臨床試驗中顯示出明顯的疼痛減輕和睡眠質量、疲勞和整體纖維肌痛症狀的改善。
2024年3月6日，Tonix Pharmicals Holding Corp. 宣佈與EVERSANA Life Science Services, LLC建立合作伙伴關係，以支持美國纖維肌痛管理候選產品Tonmya™ 的推出和商業規劃。Tonix計劃在2024年下半年向美國食品藥品管理局提交Tonmya的新藥申請，此前兩項3期試驗取得了具有統計意義的結果。該公司還計劃在2024年第二季度與美國食品藥品管理局舉行B型保密協議前會議。Tonmya，也被稱爲 TNX-102 SL，是一種非阿片類中樞作用的鎮痛藥，在臨床試驗中顯示出明顯的疼痛減輕和睡眠質量、疲勞和整體纖維肌痛症狀的改善。
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