Tonix to Host KOL Webinar on Phase 3 Fibromyalgia Trial Success

Tonix Pharmaceuticals, a biopharmaceutical enterprise, has recently unveiled promising Phase 3 results for its drug TNX-102 SL, intended to aid in the management of fibromyalgia. The company is organizing a webinar to delve into these findings and the benefits of the drug over existing treatments. The event will be led by prominent figures in the field, including Professors Daniel Clauw and Lesley Arnold, alongside Tonix's President and CEO, Seth Lederman, and Chief Medical Officer, Gregory Sullivan.

The RESILIENT study, a pivotal trial underpinning the Phase 3 data, was a double-blind, randomized, and placebo-controlled investigation. It aimed to assess the efficacy and safety of TNX-102 SL, a sublingual tablet form of cyclobenzaprine hydrochloride. The trial involved 457 participants across 33 sites in the U.S., who were initially given a lower dose before increasing to 5.6 mg or a corresponding placebo for the final 12 weeks. The study successfully met its primary goal, showing a significant improvement in daily diary pain severity scores from baseline to Week 14.

Fibromyalgia, the condition TNX-102 SL targets, is a widespread chronic pain disorder affecting an estimated 6 to 12 million adults in the U.S., predominantly women. It is characterized by chronic pain, poor sleep, fatigue, and cognitive and mood issues, severely impacting quality of life and often leading to disability. Current treatments are often met with dissatisfaction by both patients and healthcare providers.

TNX-102 SL is designed to improve sleep quality in fibromyalgia patients and offers rapid absorption and a reduced production of a long half-life metabolite. It operates as a multifunctional agent with binding and antagonist activities at various receptors. The drug is also under development for other conditions, including fibromyalgia-type Long COVID and agitation in Alzheimer's disease. Tonix holds multiple patents for TNX-102 SL, which are expected to secure market exclusivity in the U.S. until the mid-2030s.

Tonix Pharmaceuticals is dedicated to advancing therapeutics for various central nervous system disorders. The company is prioritizing the submission of a New Drug Application for TNX-102 SL and is also developing other treatments, such as TNX-1300 for cocaine intoxication and TNX-2900 for Prader-Willi syndrome. Additionally, Tonix is exploring immunology and infectious disease treatments, including vaccines for smallpox and mpox, and broad-spectrum antivirals.

The company's commercial subsidiary, Tonix Medicines, markets migraine treatment products acquired from Upsher-Smith Laboratories. Tonix Pharmaceuticals continues to focus on the development and commercialization of innovative therapies to address significant unmet medical needs.