Tonix's Tonmya Market May Expand with New Long COVID Definition by NASEM

Based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM) announced on June 11, 2041, Tonix Pharmaceuticals Holding Corp, a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today provided an update on the potential impact on the size of the fibromyalgia market for its development candidate Tonmya (TNX-102 SL or cyclobenzaprine HCl sublingual tablets).

Tonix Pharmaceuticals CEO Seth Lederman, M.D., stated, "The consensus report from the NASEM concludes that fibromyalgia is a 'diagnosable condition' in people suffering from Long COVID." "Fibromyalgia is regarded as a chronic disorder related with infections and has long been known to develop following a viral illness.2,3 According to the NASEM definition, fibromyalgia develops in some Long COVID patients subsequent to SARS-CoV-2 viral infection. In the latter part of this year, Tonix intends to submit a New Drug Application (NDA) to the FDA for Tonmya, a medication intended to treat fibromyalgia. Compared to previous market projections, we think that identifying fibromyalgia in Long COVID patients will boost the potential market for Tonmya post approval.

Dr. Lederman went on, "Fibromyalgia was thought to affect over 10 million individuals in the United States prior to the COVID-19epidemic.4 Roughly 5.3% of American adults, or 14 million people, are estimated to have long-term COVID-19, according to estimates from the U.S. Census Bureau, the National Centre for Health Statistics Household Pulse Survey, and the Centres for Disease Control and Prevention (CDC).5. Long COVID patients are frequently diagnosed with fibromyalgia.6–8. The number of Long COVID patients who fit the diagnostic criteria for fibromyalgia is unclear, however the RECOVER project, funded by the National Institutes of Health (NIH), discovered that many of them have pain at various places.

The business has previously discussed how it analysed actual data from the TriNetX claims database and found that more than 40% of Long COVID patients exhibit a set of symptoms that are similar to fibromyalgia.10, 11 After conducting a proof-of-concept trial on Long COVID patients with multisite pain, the company discovered that TNX-102 SL therapy resulted in a negligible improvement in tiredness without presenting any new safety flags. We anticipate that people experiencing chronic pain and other incapacitating symptoms will be able to obtain the necessary care thanks to our revised definition of Long COVID.