CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.The fibromyalgia market has not seen a new FDA-approved drug in over 15 years.

新泽西州查塔姆/ACCESSWIRE/2024年7月17日/Tonix Pharmaceuticals Holding Corp.（NASDAQ:TNXP）与FDA的最后一次NDA前会议结束后，宣布将于2024年下半年提交NDA提交文件，并制定计划，假设2025年下半年获得FDA批准，将商业推出用于治疗纤维肌痛的Tonmya™*。纤维肌痛市场已有15年多没有FDA批准的新药。

And now with two drugs making their way through the FDA - Tonix's Tonmya and one from another U.S. company - there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.Fibromyalgia LandscapeAccording to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix's drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States.

现在，有两种药物通过了美国食品和药物管理局（FDA）的批准，即Tonix的Tonmya和另一家美国公司的Tonmya，可能会出现两种药物的竞争，让人想起20世纪10年代，当时两种畅销的纤维肌痛药物共同创造了100亿美元的峰值销售额。纤维肌痛景观根据Tonix委托Eversana对Tonix的药物Tonmya™进行的机会分析，纤维肌痛影响了美国约270万确诊和治疗的患者。

Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5 billion each.

尽管这种情况的患病率很高，但治疗情况在15年多的时间里基本上保持停滞。最后一种批准的药物于2009年获得批准，之前的两种药物于2008年和2007年获得批准。尽管广泛报道了副作用和耐受性问题，但两种销量最大的纤维肌痛药物各自产生了约50亿美元的峰值销售额。

Both are now generic. A big difference about the fibromyalgia market today is that the condition is widely accepted. Before the heydays of the two blockbusters, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a comp.

现在两者都是通用的。今天纤维肌痛市场的一大区别是这种情况被广泛接受。在这两部大片全盛期之前，由于缺乏明显的体征和具体的诊断测试，许多医生怀疑纤维肌痛的存在。许多人认为纤维肌痛被忽视了，因为它主要影响女性。Tonix将在2023年价值超过30亿美元的全球市场上争夺一块份额，预计该市场将以较低的价格增长。