On Tuesday, Tonix Pharmaceuticals (NASDAQ:TNXP) saw its stock double in premarket trading after the U.S. Food and Drug Administration (FDA) accepted its marketing application for TNX-102 SL, heralding promising times for the company and those grappling with fibromyalgia. This acceptance marks the beginning of what could be significant changes for patients seeking new treatment options for this chronic pain condition.
Fibromyalgia, impacting over 10 million adults across the United States, predominantly women, has been notoriously hard to treat. The FDA’s nod for TNX-102 SL—a non-opioid analgesic—could pave the way for the first new medication aimed at fibromyalgia management to hit the market since 2004. According to Seth Lederman, M.D., the CEO of Tonix Pharmaceuticals, this development is not just about the drug itself; it is about providing hope to the fibromyalgia community, which has been waiting for over 15 years for new solutions.
The Federal agency is anticipated to assign the Prescription Drug User Fee Act (PDUFA) target action date soon. This date will inform Tonix whether their request for Priority Review has been granted. Such designations are typically provided for drugs aiming to address serious conditions and fulfill unmet medical needs.
Dr. Lederman expressed optimism following the acceptance, highlighting the lack of treatment advancements for fibromyalgia since the last approved medication over 15 years ago. He noted, "The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years." This couldn’t come at a more urgent time when many fibromyalgia patients find themselves prescribed addictive opioids rather than modern pain management alternatives.
TNX-102 SL, which is taken as sublingual tablets, is formulated with 5.6 mg of cyclobenzaprine hydrochloride. It has been granted Fast Track status, which indicates the urgency and importance of this drug’s potential. The formulation is acclaimed for its effectiveness at targeting non-restorative sleep—a significant symptom of fibromyalgia—as identified by Professor Harvey Moldofsky back in 1975.
The acceptance of the New Drug Application (NDA) is backed by evidence gathered from two Phase 3 clinical trials: the RELIEF trial, which concluded successfully back in December 2020, and the more recent RESILIENT trial completed just last month. Both studies showed statistically significant reductions in daily pain when measured against placebo, establishing the efficacy of TNX-102 SL. Most impressively, the RESILIENT study noted results with p=0.00005, which reflects a very strong outcome.
While patients can expect some common side effects associated with medication, TNX-102 SL was reported to be well-tolerated overall. The most frequent adverse event experienced by participants was experienced as tongue or mouth numbness during treatment. Importantly, this symptom was temporary and self-limiting.
Fibromyalgia, which was classified as nociplastic pain, describes discomfort stemming from altered pain processing within the nervous system. Symptoms extend beyond pain alone—affected individuals often discuss problems with fatigue, poor sleep, and cognitive deficits, frequently referred to as “brain fog.” These symptoms can drastically affect quality of life, limiting the ability to maintain normal daily activities.
The chronic pain disorder often develops due to events like surgery, infections, or extreme stress. Interestingly, recent research also links fibromyalgia to Long COVID, with individuals recovering from the virus experiencing symptoms typical of the condition. Fibromyalgia is now recognized as part of what health officials categorize as Chronic Overlapping Pain Conditions, which also includes ailments like chronic fatigue syndrome and endometriosis.
For Tonix Pharmaceuticals, the acceptance of the NDA is just another milestone as they look forward to commercially launching the drug—pending FDA approval, of course. The company is preparing for this possibility, hoping to see TNX-102 SL come to market as early as 2025.
Beyond TNX-102 SL, Tonix is also involved with various programs aimed at addressing other central nervous system disorders. This includes developments targeting anxiety and acute stress, directing research initiatives to offer new therapies to those affected by these issues.
While potential approval remains on the horizon, Tonix Pharmaceuticals’ commitment to advancing its product lineup including TNX-102 SL signals hope for many fibromyalgia sufferers who have long awaited innovative treatment options.