Tonix Pharmaceuticals Presented TNX-102 SL Fibromyalgia Data at IASP 2024 Congress

Tonix Pharmaceuticals Holding Corp. has announced significant advancements in the treatment of fibromyalgia with their investigational drug, TNX-102 SL (sublingual cyclobenzaprine HCl). The company's Phase 3 RESILIENT study has shown that TNX-102 SL significantly improves both primary and secondary endpoints related to fibromyalgia, including nociplastic pain and sleep quality.

Fibromyalgia is a chronic pain disorder characterized by widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction. It affects over 10 million adults in the U.S., predominantly women. Current treatments often fail to provide satisfactory relief, leading to a compromised quality of life for many sufferers.

Tonix Pharmaceuticals presented their findings at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain. The presentation highlighted the broad syndromal benefits of TNX-102 SL, including significant improvements in sleep quality, fatigue reduction, and overall fibromyalgia symptoms. Additionally, post hoc analyses revealed strong correlations between improvements in pain and sleep quality, suggesting that enhancing sleep quality can lead to overall symptom improvement in fibromyalgia.

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, noted that the importance of non-restorative sleep in the pathogenesis and persistence of fibromyalgia is well-established. The drug was designed to target non-restorative sleep, and the positive results from two Phase 3 studies support its efficacy and tolerability. Dr. Lederman emphasized that these findings reinforce the critical role of sleep quality in managing fibromyalgia.

Greg Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, explained that fibromyalgia is now recognized as a prototypic "nociplastic syndrome," a category of pain resulting from altered pain processing in the central nervous system. Traditional pain relievers like NSAIDs and opioids are often ineffective for such conditions, making TNX-102 SL a potentially groundbreaking treatment option. The drug demonstrated broad-spectrum symptom relief in the RESILIENT study, positioning it as a possible new treatment for fibromyalgia, which has seen little innovation in the past 15 years.

TNX-102 SL has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Tonix Pharmaceuticals is on schedule to submit a New Drug Application (NDA) in the second half of 2024. The company's development portfolio includes other CNS disorders, with TNX-102 SL also being explored for acute stress reaction.

The company's commercial subsidiary, Tonix Medicines, currently markets products for migraine treatment, including Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray).

In summary, Tonix Pharmaceuticals' TNX-102 SL has shown promising results in treating fibromyalgia, focusing on improving sleep quality to alleviate broader symptoms. With Fast Track designation and plans for an NDA submission underway, TNX-102 SL could soon offer a new hope for patients suffering from this chronic condition.