Topline Data from a Registration-Enabling Phase 3 Clinical Trial is Due Later This Month.

CHATHAM, NJ / ACCESSWIRE / December 14, 2023 / Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep problems and brain fog. It is a complex condition that often overlaps with other chronic conditions such as COVID. There are an estimated 10 million U.S. adults - about 2% of the population - living with the disorder and, unfortunately, it has a high unmet need. The diagnosis of fibromyalgia can also be challenging as there are no specific laboratory tests or imaging studies to confirm it, and the symptoms can vary from person to person.

Currently, available treatments for fibromyalgia aim to manage symptoms and improve overall quality of life. They often involve a multidisciplinary approach that combines medication, physical therapy, exercise and lifestyle changes. Commonly prescribed medications for fibromyalgia include three FDA-approved drugs - Lyrica, Cymbalta and Savella. Patients also often use other medicines such as antidepressants, anticonvulsants and pain relievers, including opioids.

However, despite the range of available treatment options, there hasn't been a new FDA-approved drug for fibromyalgia for over a decade. This has led to widespread dissatisfaction among patients and healthcare providers. One major concern with the current fibromyalgia drugs is the issue of tolerance, where individuals may become less responsive to the medication over time, requiring higher doses or switching between different medications. This can lead to a frustrating cycle of trial and error to find an effective treatment. Unfortunately, a concerning number of individuals with fibromyalgia end up relying on opioids for pain relief, which can lead to further complications and potential addiction.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company that focuses on the development and commercialization of therapies for pain and neurological conditions such as migraine headaches, is looking to change the treatment options available to people struggling with fibromyalgia.

One of the drugs in Tonix's pipeline is TNX-102 SL. TNX-102 SL is a sublingual, or under-the-tongue, formulation of cyclobenzaprine, a muscle relaxant that also interacts with receptors in the brain associated with sleep quality. It is being investigated for the management of fibromyalgia. TNX-102 SL showed efficacy in improving fatigue in a clinical trial.

The company recently announced the completion of the clinical phase of the RESILIENT study for the drug. This phase 3 registration-quality, double-blind, placebo-controlled study evaluated the efficacy and safety of TNX-102 SL at a dose of 5.6 mg for the management of fibromyalgia. The study included 457 patients enrolled across multiple sites in the United States. The company is anticipating topline results by the end of December 2023, which, if successful, is expected to be the final trial required for the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).

This would be the second positive phase 3 trial for the company following the positive results from the first phase 3 RELIEF trial in December 2020, focusing on the management of fibromyalgia. In the RELIEF study, TNX-102 SL at a dose of 5.6 mg and as compared to placebo revealed a statistically significant reduction in daily pain (p=0.01) in participants with fibromyalgia. A higher rate of responders to TNX-102 SL (47%) was observed than to placebo (35%; p=0.006) when the analysis was performed as a ≥30% pain responder analysis. TNX-102 SL at 5.6 mg showed activity in key secondary endpoints, which included improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. The drug candidate was found to be well-tolerated among patients with fibromyalgia, having a safety profile comparable to TNX-102 SL in previous fibromyalgia trials. The most commonly reported treatment-emergent adverse effects could be described as tongue numbness (officially called oral hypoesthesia), oral paresthesia and product taste abnormality.

TNX-102 SL's application in the treatment of PTSD-related syndromes is also gaining traction. The company reports that the U.S. Department of Defense (DoD) is supporting the upcoming phase 2 study of TNX-102 SL in acute stress disorder, which is a precursor to PTSD. The trial will be conducted and sponsored by the University of North Carolina. A $3 million grant is expected to support a trial that will enroll approximately 180 patients at U.S. study sites who experience trauma from motor vehicle accidents. Enrollment is expected to initiate at the beginning of 2024. In light of these developments and the potential success of the company's other drugs in the pipeline, Tonix has several programs demonstrating considerable promise.

Fibromyalgia is a complex and challenging disorder that affects millions of individuals worldwide. The anticipated topline results by the end of December 2023, if successful, could support the submission of a New Drug Application (NDA) to the FDA. Tonix's efforts hold the potential to bring relief and improve the quality of life for those struggling with this debilitating disorder.

*Tonix's product development candidates, including TNX-102 SL, are investigational new drugs or biologics and have not been approved for any indication.

Featured photo by National Cancer Institute on Unsplash.

Contact:

Tonix Pharmaceuticals Holding Corp.
Jessica Morris (corporate)
investor.relations@tonixpharma.com

SOURCE: Tonix Pharmaceuticals