CHATHAM, N.J., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial biotechnology company, announced today that a poster on Tonmya™ (cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, will be presented by Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, at the 2025 American College of Rheumatology Convergence, being held October 24–29, 2025, in Chicago, Ill. A cop ...

Core Insights - Tonix Pharmaceuticals is advancing TNX-102 SL, a potential first-in-class treatment for major depressive disorder (MDD), with an IND application expected in Q4 2025 [1][3] - TNX-102 SL is already FDA-approved for fibromyalgia and is being explored for its effects on sleep quality and depressive symptoms [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [5] - The company recently received FDA approval for Tonmya™, a non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, and infectious diseases [6] Product Development - TNX-102 SL is a patented sublingual formulation designed for rapid absorption, bypassing first-pass metabolism, and is currently approved for fibromyalgia [4] - The drug is also being developed for other indications, including acute stress reaction, PTSD, and Long COVID [4] - The FDA provided positive feedback during the Pre-IND meeting, indicating a reasonable long-term safety data collection plan [2][3] Clinical Data - In the Phase 3 RESILIENT study, TNX-102 SL showed significant improvement in depressive symptoms among fibromyalgia patients compared to placebo, with a p-value of less than 0.05 [3] - The biological relationship between depressive symptoms in fibromyalgia and MDD remains unclear [3] Intellectual Property - Tonix holds multiple patents related to TNX-102 SL, providing market exclusivity until at least 2034, with potential extensions until 2044 for method of use [4]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges [4] - The company operates a state-of-the-art infectious disease research facility in Frederick, MD, and its development portfolio includes central nervous system disorders, immunology, and infectious diseases [4] Campaign Launch - Tonix Medicines, Inc., a commercial subsidiary of Tonix Pharmaceuticals, launched the "Move Fibro Forward" campaign to raise awareness and support for individuals affected by fibromyalgia [1][2] - The campaign aims to validate the experiences of those suffering from fibromyalgia and encourage them to seek education and resources [2] Fibromyalgia Insights - Fibromyalgia is a chronic pain disorder affecting an estimated 10 million adults in the U.S., with approximately 90% being women [3] - Common symptoms include chronic widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction, leading to impaired quality of life and frequent disability [3]

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, with an FDA PDUFA goal date of August 15, 2025, potentially becoming the first new non-opioid analgesic for fibromyalgia in over 15 years [1][7] - The drug has shown statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies, demonstrating durable activity over 14 weeks [2][3] - TNX-102 SL targets sleep disturbances associated with fibromyalgia and has a favorable tolerability profile, acting as a potent antagonist at four post-synaptic receptors [3][6] Company Overview - Tonix Pharmaceuticals is a biotechnology company focused on developing therapies for pain management and CNS disorders, with TNX-102 SL as a priority product candidate for fibromyalgia [7] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on positive Phase 3 study results and has received Fast Track designation from the FDA [7] - Tonix also has a diverse development portfolio, including treatments for acute stress reactions, organ transplant rejection, and infectious diseases [7] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, non-restorative sleep, and cognitive dysfunction [4] - Current treatment options are often unsatisfactory, leading many patients to rely on chronic opioids, which carry risks of addiction and overdose [2][4] - TNX-102 SL's unique formulation aims to provide a new therapeutic option that addresses both pain and sleep disturbances without the risks associated with opioids [2][6]