FDA Grants Fast Track for Tonix's Tonmya™ for Fibromyalgia

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical firm based in Chatham, N.J., announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for managing fibromyalgia. This designation aims to accelerate the FDA's review process for new drugs that address severe conditions and unmet medical needs. Fibromyalgia, a chronic pain disorder affecting over 10 million adults in the U.S., is particularly prevalent among women.

Tonmya is a non-opioid, centrally-acting analgesic under development for fibromyalgia treatment. The FDA's Fast Track designation underscores the significant impact of fibromyalgia and Tonmya's potential to fulfill an unmet medical need. Following pre-New Drug Application (NDA) meetings, Tonix Pharmaceuticals plans to submit the NDA for Tonmya in the latter half of 2024. If approved, Tonmya would be the first new drug for fibromyalgia in over 15 years and is intended for long-term daily use at bedtime.

Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, stated that the Fast Track designation supports the company's goal of bringing this non-opioid treatment to the market by 2025. Dr. Lederman emphasized the importance of addressing the needs of fibromyalgia patients who are often dissatisfied with current treatments. The company anticipates that Tonmya could become a primary therapy for fibromyalgia, with the NDA supporting its potential as a first-line treatment.

The Fast Track process facilitates the development and review of drugs meant to treat serious conditions and address unmet needs, potentially bringing vital new medications to patients more quickly. Companies with Fast Track designation can engage in more frequent interactions with the FDA during clinical development. Additionally, Tonix Pharmaceuticals plans to request Priority Review designation, which could further speed up the NDA review process.

Tonmya, also known as TNX-102 SL, is a patented sublingual formulation of cyclobenzaprine hydrochloride, designed for bedtime use. In December 2023, Tonix Pharmaceuticals reported significant and clinically meaningful results from the RESILIENT Phase 3 trial, where Tonmya significantly reduced daily pain compared to a placebo. Positive results were also observed in key secondary endpoints, including improved sleep quality, reduced fatigue, and enhanced overall fibromyalgia symptoms. The RELIEF Phase 3 trial, completed in December 2020, also showed significant results in pain reduction and secondary endpoints. The most common side effect in both trials was temporary numbness in the tongue or mouth, which was generally mild and did not often lead to discontinuation.

Fibromyalgia is characterized by chronic widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction. It affects between 6 million to 12 million adults in the U.S., primarily women. Patients with fibromyalgia often experience a reduced quality of life and disability due to the disorder. Current treatments have not fully satisfied patients or physicians.

Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for central nervous system disorders, among other conditions. The company’s primary goal is to submit an NDA for Tonmya in 2024, following successful Phase 3 studies. Their portfolio also includes treatments for acute stress reaction, cocaine intoxication, organ transplant rejection, autoimmunity, and cancer. Tonix’s commercial subsidiary markets treatments for acute migraines, illustrating the company’s broad therapeutic range and commitment to addressing various medical needs.