Tonmya™ Shows "Brain Fog" Improvement in Fibromyalgia Patients in RESILIENT Study

Tonix Pharmaceuticals recently reported positive outcomes from the Phase 3 RESILIENT study of Tonmya for fibromyalgia management. The study demonstrated a significant reduction in daily pain and improvements across six secondary endpoints, including sleep, fatigue, and cognitive function. Tonmya, a cyclobenzaprine HCl sublingual tablet, showed its effectiveness in treating fibromyalgia symptoms comprehensively. The drug's impact on cognitive function, often referred to as "brain fog," was particularly notable, with a statistically significant improvement in memory issues as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQ-R).

Dr. Seth Lederman, President and CEO of Tonix Pharmaceuticals, highlighted the broad-spectrum activity of Tonmya, suggesting that it treats fibromyalgia at a systemic level. The RESILIENT study's results build on the success of the RELIEF trial, which also showed a reduction in daily pain. Tonix plans to submit a New Drug Application (NDA) to the FDA in 2024, following a pre-NDA meeting scheduled for the second quarter of the same year.

Importantly, Tonmya did not cause increases in blood pressure or body weight, common side effects associated with other fibromyalgia treatments. Additionally, it showed no reported sexual side effects and even improved sexual function in women, as measured by the Changes in Sexual Functioning Questionnaire short form (CSFQ-14). Dr. Gregory Sullivan, Tonix's Chief Medical Officer, emphasized the significance of these tolerability factors for patients on long-term treatment.

The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 participants across 33 U.S. sites. The study design included an initial two-week run-in period followed by a 12-week treatment phase. The primary endpoint focused on the daily diary pain severity score change from baseline to Week 14. The study's most common adverse events were mild and transient local reactions at the administration site.

Fibromyalgia is a chronic pain disorder affecting an estimated 6 to 12 million adults in the U.S., predominantly women. The condition is characterized by widespread pain, sleep issues, fatigue, and cognitive dysfunction, significantly impacting the quality of life for those affected. Current treatments often fail to meet patient and physician expectations, highlighting the need for new therapeutic options.

Tonmya, as a non-opioid and non-addictive medication, offers a potential new first-line treatment for fibromyalgia with a favorable side effect profile. The drug's development is part of Tonix's broader focus on central nervous system disorders, with a commitment to improving patient outcomes and quality of life. With the positive results from the RESILIENT study, Tonix is optimistic about the potential for Tonmya to become the first FDA-approved drug for fibromyalgia in over a decade, providing hope for millions of affected individuals.