Tonix Pharmaceuticals Presented TNX-102 SL Fibromyalgia Data at 2024 MHSRS

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company, announced promising results from their Phase 3 RESILIENT study on TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride. The treatment was shown to significantly reduce daily pain in fibromyalgia patients, meeting the primary study endpoint. Additionally, TNX-102 SL demonstrated statistically significant improvements across all six key secondary endpoints, which included enhancements in sleep quality, reduction of fatigue, and overall betterment of fibromyalgia symptoms and function.

An oral presentation on this study, titled "Assuaging Agony: Novel Pain Therapeutics," was delivered at the 2024 Military Health System Research Symposium. Post hoc analyses underscored strong correlations between pain reduction and improved sleep quality at Week 14, suggesting that targeting sleep quality can lead to comprehensive symptom relief in fibromyalgia. TNX-102 SL was well-tolerated among participants, with an adverse event profile consistent with prior studies and no newly emerging safety concerns.

Seth Lederman, CEO of Tonix Pharmaceuticals, emphasized the limitations of traditional analgesics like NSAIDs and opioids in treating fibromyalgia. In contrast, TNX-102 SL is designed to address non-restorative sleep, ultimately enhancing sleep quality. With two positive Phase 3 studies under its belt, TNX-102 SL has the potential to become the first new treatment for fibromyalgia in 15 years.

Fibromyalgia is a chronic pain disorder marked by amplified pain signaling within the central nervous system, affecting over 10 million adults in the U.S., predominantly women. Symptoms include chronic widespread pain, non-restorative sleep, fatigue, cognitive dysfunction, mood disturbances, headaches, and abdominal pain. These symptoms severely impact daily activities and quality of life. Many patients and physicians express dissatisfaction with currently available treatments, and fibromyalgia is also recognized as a diagnosable condition that may occur in the context of Long COVID.

TNX-102 SL aims to address these shortcomings as a centrally acting, non-opioid, non-addictive bedtime medication. The drug has shown promising results, achieving a significant reduction in daily pain and improvements in secondary outcomes like sleep quality and fatigue in its second pivotal Phase 3 trial. The first pivotal Phase 3 trial, completed in December 2020, also yielded positive results, meeting its primary endpoint and showing activity in key secondary endpoints. Common treatment-related adverse events included temporary tongue or mouth numbness, which was generally mild and rarely led to discontinuation.

The FDA has granted Fast Track Designation to TNX-102 SL for the management of fibromyalgia, and Tonix plans to submit a New Drug Application (NDA) to the FDA in the latter half of 2024, with an approval decision expected in 2025.

Nociplastic pain, the type of pain seen in fibromyalgia, originates from altered pain perception in the brain, rather than from direct tissue damage or nerve injury. This type of pain is characterized by central sensitization, where central nervous system neurons become hyperexcitable, amplifying pain signals. Nociplastic syndromes also include chronic overlapping pain conditions such as chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, chronic back pain, and chronic headache.

Tonix Pharmaceuticals is committed to developing therapies for CNS disorders, with a focus on submitting the NDA for TNX-102 SL for fibromyalgia. Their portfolio includes candidates for treating acute stress reactions, cocaine intoxication, organ transplant rejection, autoimmunity, cancer, and rare diseases. The company also markets Zembrace SymTouch and Tosymra for acute migraine treatment.

Tonix’s dedication to addressing unmet medical needs in pain management and other CNS disorders positions TNX-102 SL as a promising new treatment option for fibromyalgia, potentially benefiting millions of patients struggling with this debilitating condition.