Tonix Pharmaceuticals Announces PDUFA Goal Date Of August 15, 2025, For FDA Decision On U.S. Marketing Approval For TNX-102 SL For Fibromyalgia; NDA Based On Two Statistically Significant Phase 3 Studies Of TNX-102 SL For The Management Of Fibromyalgia, In Which TNX-102 SL Was Generally Well Tolerated
Tonix received FDA's Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025
TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA
Fibromyalgia affects more than 10 million adults in the U.S., who are mostly women
TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and first new drug for its treatment in more than 15 years
NDA based on two statistically significant Phase 3 studies of TNX-102 SL for the management of fibromyalgia, in which TNX-102 SL was generally well tolerated
CHATHAM, N.J., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.
Tonix Pharmaceuticals宣佈,FDA對於TNX-102 SL治療纖維肌痛的美國市場批准的PDUFA目標日期爲2025年8月15日;NDA基於兩項統計學上顯著的TNX-102 SL的第3階段研究,TNX-102 SL通常耐受良好
Tonix收到了FDA的第74天函件,授予TNX-102 SL一個PDUFA目標日期爲2025年8月15日
TNX-102 SL是一種非阿片類,中央作用的鎮痛藥,已獲得FDA的快速通道認證
纖維肌痛在美國影響超過1000萬成年人,主要是女性
TNX-102 SL有潛力成爲治療纖維肌痛新類別鎮痛藥的首位成員,也是15年來首個用於該病治療的新藥
NDA基於兩項統計學上顯著的TNX-102 SL的第3階段研究,TNX-102 SL通常耐受良好
新澤西州查塔姆,2024年12月23日(環球新聞通訊社)-- Tonix Pharmaceuticals Holding CORP.(納斯達克:TNXP)(Tonix或公司)今日宣佈,美國食品和藥物管理局(FDA)爲TNX-102 SL(鹽酸環抱撲林舌下片)在纖維肌痛上的市場批准決定分配了2025年8月15日的PDUFA目標日期。TNX-102 SL是一種非阿片類、中央作用的鎮痛藥。纖維肌痛是一種影響主要是女性的常見慢性疼痛控制項。