Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, is developing TNX-102 SL, a new nonaddictive treatment for fibromyalgia, the prototypic nociplastic pain syndrome. According to a recent post, research into the causes and nature of pain is increasing; the post observed that there were more than 400 scientific presentations at the 2024 Word Congress on Pain, which was held Aug. 6–9, 2024, and was sponsored by the International Association for the Study of Pain. The article noted there different types of pain have been identified: nociceptive pain, neuropathic pain and nociplastic pain.
Tonix Pharmaceuticals’ TNX-102 SL was recently granted Fast Track designation by the U.S. Food and Drug Administration, which is designed to facilitate development and expedite the review of important new drugs intended to treat serious conditions and address unmet medical needs. Tonix is now working to finalize filing of a New Drug Application (“NDA”) for TNX-102 SL; the company anticipates submitting the NDA later this year.
“Nociplastic pain is the third primary type of pain and one of the most challenging to treat,” said Tonix Pharmaceuticals CEOSeth Lederman, MD, in the press release. “Think of nociplastic pain as being caused by a software bug in a certain part of the brain that exaggerates sensory experiences and turns them into feelings of real pain. . . . The Fast-Track designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options. If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years.”
To view the full post, visit https://ibn.fm/3ISan
About Tonix Pharmaceuticals Holding Corp.
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya, a product candidate for which two positive phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ-transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (“CD40L” or “CD154”) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R) (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about the company, please visit www.TonixPharma.com.
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