Tonix Pharmaceuticals' NDA for TNX-102 SL for Fibromyalgia Accepted by FDA

CHATHAM, N.J., Dec. 17, 2024 - Tonix Pharmaceuticals Holding Corp. announced a significant milestone with the U.S. Food and Drug Administration's (FDA) acceptance of their New Drug Application (NDA) for TNX-102 SL, a novel treatment targeting fibromyalgia. This drug, comprising 5.6 mg of cyclobenzaprine HCl in sublingual tablet form, is a non-opioid analgesic that acts centrally to manage fibromyalgia, a condition affecting over 10 million Americans.

The FDA's review process will include assigning a target action date through the Prescription Drug User Fee Act (PDUFA) and determining the possibility of a Priority Review. This NDA marks progress towards introducing a new drug class to the fibromyalgia treatment arena, a space that has not seen a new drug in over 15 years. Tonix's CEO, Dr. Seth Lederman, highlighted the unmet needs of the fibromyalgia community, pointing out that many patients, post-diagnosis, were more likely to receive opioid prescriptions over existing FDA-approved medications.

The NDA is backed by robust data from two pivotal Phase 3 clinical trials. The RELIEF study, completed in December 2020, demonstrated significant pain reduction in patients using TNX-102 SL compared to a placebo. Similarly, the RESILIENT study, concluded in December 2023, reaffirmed these positive outcomes. Both trials showed that the drug was generally well-tolerated, with most common side effects being temporary and mild, such as numbness in the mouth or tongue. Systemic adverse events remained minimal, under 4%, in both studies.

TNX-102 SL's formulation is specifically crafted for sublingual administration, providing rapid absorption into the bloodstream while minimizing daytime drowsiness. Unlike traditional oral cyclobenzaprine, TNX-102 SL avoids first-pass hepatic metabolism, resulting in better therapeutic exposure early on and fewer side effects related to its long-lived metabolite.

Fibromyalgia, characterized by chronic pain, non-restorative sleep, and cognitive impairments, is a complex disorder believed to arise from heightened sensory and pain processing in the brain. More prevalent in women, fibromyalgia's symptoms include fatigue, mood disturbances, and cognitive dysfunction, often complicating daily life. This condition, now recognized as a nociplastic pain syndrome, can occur without clear triggers or following stressors like surgery, infections, or trauma.

Tonix Pharmaceuticals, a biopharmaceutical firm, is dedicated to developing therapies for central nervous system disorders. They are advancing TNX-102 SL for fibromyalgia management and investigating its potential for treating acute stress reactions. Additionally, Tonix is working on TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Their research efforts extend to rare and infectious diseases, with TNX-2900 for Prader-Willi syndrome and an mpox vaccine, TNX-801. A recent contract with the U.S. Department of Defense supports their development of antiviral agents, emphasizing Tonix's commitment to addressing diverse medical challenges.

The acceptance of TNX-102 SL's NDA is a promising stride towards offering new hope to fibromyalgia patients. With continued collaboration with the FDA, Tonix aims to bring this potentially groundbreaking therapy to market by 2025, reinforcing its leadership in developing innovative pain management solutions.