CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, has reported positive results from its Phase 3 RESILIENT study of Tonmya, a treatment for fibromyalgia. The study met its primary endpoint of daily pain reduction and achieved significant improvement across all six key secondary endpoints.
Tonmya, also known as TNX-102 SL, is a sublingual tablet formulation of cyclobenzaprine HCl. The RESILIENT study, which included 457 participants across 33 U.S. sites, demonstrated that Tonmya significantly reduced daily pain compared to placebo with a p-value of 0.00005. The trial also showed nominal improvement in cognitive dysfunction or "brain fog," as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item, with a p-value of 0.001.
In addition to the primary pain reduction endpoint, the study observed statistically significant improvements in sleep quality, fatigue, and overall fibromyalgia symptoms and function. The effect sizes for these secondary outcomes ranged from 0.3 to 0.5.
Tonix Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024, following a pre-NDA meeting scheduled for the second quarter of 2024. If approved, Tonmya could become the first FDA-approved drug for fibromyalgia in over a decade.
According to Dr. Seth Lederman, President and CEO of Tonix Pharmaceuticals, the data suggest that Tonmya may treat fibromyalgia at a syndromal level, offering broad-spectrum activity. Dr. Gregory Sullivan, Chief Medical Officer, highlighted the importance of the drug's tolerability, noting that it was not associated with common side effects such as increased blood pressure, body weight changes, or sexual side effects, which are concerns with other FDA-approved drugs for fibromyalgia.
The RESILIENT study's results may offer hope to the estimated 6 to 12 million adults in the U.S. affected by fibromyalgia, a chronic pain disorder characterized by widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction.
These findings are based on a press release statement from Tonix Pharmaceuticals Holding Corp. and have not been independently verified. The company's product candidates are investigational new drugs and have not been approved for any indication.
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