BioMedNewsBreaks — Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Developing Fast-Track-Designated Treatment for Fibromyalgia

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.

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.BioMedWire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer

BioMedWire
San Francisco, CA
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com

BioMedWire is powered by IBN

Data & News supplied by www.cloudquote.io
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.