Hope On The Horizon: Tonix Pharmaceuticals (NASDAQ:TNXP) Could Be On the Cusp of Changing Fibromyalgia Treatment Options With TNX-102 SL

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.

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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.