Tonix Pharmaceuticals Submits TNX-102 SL NDA for Fibromyalgia to FDA

Tonix Pharmaceuticals Holding Corp. has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL, a novel medication aimed at reducing the chronic, widespread pain associated with fibromyalgia. This submission marks a significant step forward for the company in addressing the needs of the fibromyalgia patient population, which has not seen a new pharmacotherapy in over 15 years.

TNX-102 SL is a non-opioid, centrally acting analgesic designed for bedtime use. Its development was based on two Phase 3 clinical trials, RELIEF and RESILIENT, both of which demonstrated statistically significant reductions in daily pain compared to placebos. In these trials, TNX-102 SL was well-tolerated, with the most common side effect being temporary tongue or mouth numbness, which rarely led to study discontinuation.

Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, highlighted the importance of this development, emphasizing that TNX-102 SL could become the first member of a new class of medicines specifically for fibromyalgia. The drug targets non-restorative sleep, a key characteristic of fibromyalgia, potentially offering substantial relief to patients.

The submission of the NDA is bolstered by data from the Phase 3 studies. The RELIEF trial, completed in December 2020, and the RESILIENT trial, completed in December 2023, both met their primary endpoints, showing significant pain reduction. These results support the efficacy and safety of TNX-102 SL, making a strong case for its approval.

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, noted the current limitations of existing fibromyalgia treatments, which include gabapentinoids like Pfizer's Lyrica and SNRIs like Lilly's Cymbalta and AbbVie's Savella. If approved, TNX-102 SL would be the first tricyclic class medication for fibromyalgia, offering a new treatment avenue for patients dissatisfied with current options.

Fibromyalgia is a chronic pain disorder affecting over 10 million adults in the U.S., predominantly women. The condition is characterized by symptoms such as widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction. These symptoms significantly impair daily activities and quality of life, often leading to disability. Despite the availability of three FDA-approved medications, there remains a significant unmet need for new treatments.

TNX-102 SL is a sublingual tablet based on a eutectic formulation of cyclobenzaprine HCl and mannitol, designed for rapid dissolution and efficient transmucosal absorption. This formulation minimizes the risk of daytime somnolence and aims to improve sleep quality, addressing one of the core issues in fibromyalgia.

If the FDA accepts the NDA for review, a decision is expected in 2025. The approval of TNX-102 SL would not only offer a new therapeutic option for fibromyalgia patients but also represent a breakthrough in the treatment landscape for this challenging condition.

The development of TNX-102 SL is part of Tonix's broader commitment to innovative therapies for central nervous system disorders. The company's portfolio includes other promising candidates, such as TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Tonix is also exploring treatments for rare diseases and infectious conditions, underscoring its dedication to addressing diverse and unmet medical needs.

Overall, the submission of the NDA for TNX-102 SL marks a hopeful step towards providing a new, effective treatment for fibromyalgia, potentially transforming the lives of millions of patients struggling with this debilitating disorder.