Tonix Pharmaceuticals gains FDA approval for new fibromyalgia treatment

In the United States, Tonix Pharmaceuticals Holding Corp. has achieved a significant milestone with the approval of Tonmya (cyclobenzaprine HCl sublingual tablets) by the U.S. Food and Drug Administration (FDA) for treating fibromyalgia in adults. This chronic condition, known for causing widespread pain, fatigue, and various cognitive challenges, can severely affect the quality of life of those suffering from it. The FDA's approval was based on findings from two Phase 3 clinical trials, involving nearly 1,000 patients, where Tonmya demonstrated a statistically significant reduction in daily pain scores when compared to a placebo over a 14-week period. Additionally, the trials indicated that a higher proportion of participants taking Tonmya experienced clinically meaningful improvements in pain after three months, further validating its efficacy. The most recent Phase 3 trial, known as RESILIENT, has contributed valuable data that includes not only pain metrics but also patient-reported symptoms, sleep disturbances, fatigue, and overall patient wellness, which were documented in a publication in Pain Medicine. This extensive evidence of effectiveness, coupled with good tolerability demonstrated across three Phase 3 trials involving over 1,400 patients, positions Tonmya as a promising option for fibromyalgia management. Anticipation surrounds the U.S. launch of Tonmya, which is expected to be available to patients starting in the fourth quarter of this year. Tonix Pharmaceuticals has also shown financial resilience, concluding the June quarter with cash and cash equivalents amounting to $125.3 million. This financial stability is projected to support the company's operations into the third quarter of 2026, ensuring that it can effectively market and distribute Tonmya once it hits the shelves. The timing of this approval is particularly noteworthy as the FDA had issued a 'refusal to file' letter to Axsome Therapeutics, Inc. regarding its own treatment for fibromyalgia, AXS-14, marking a significant legislative shift in the landscape for fibromyalgia therapies which could enhance Tonix's market standing. The approval of Tonmya represents a crucial development within the realm of chronic pain management, offering hope to countless adults living with fibromyalgia. The data and research backing this new treatment underscore the commitment of Tonix Pharmaceuticals to deliver effective solutions to a condition that affects millions, thereby enhancing patient quality of life and offering a new avenue for physicians treating this challenging disorder.