Additional data highlighting the favorable tolerability and differentiated side effect profile of TNX 102 SL in second positive phase III clinical trial for the management of fibromyalgia

As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. Tonix plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX 102 SL for the management of fibromyalgia.

RELIEF, the first Phase III trial of TNX 102 SL 5.6 mg in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

In presenting more detailed data from the RESILIENT study, Seth Lederman, M.D., President and Chief Executive Officer of Tonix, said, “The results showed that TNX 102 SL treatment was not associated with increases in systolic or diastolic blood pressure or body weight, nor were there any reported sexual side effects. In fact, when systematically investigated using the Changes in Sexual Functioning Questionnaire short form (CSFQ-14), women who received study drug had a higher CSFQ-14 score relative to those who received placebo consistent with improved sexual function. These are important tolerability factors for fibromyalgia patients on long-term therapies, particularly since weight gain is associated with gabapentinoids, negative sexual side effects are associated with serotonin-reuptake inhibiting medications, and increased blood pressure is associated with potent noradrenergic-reuptake inhibiting medications.”

Dr. Lederman added, “We believe that the data from our two positive Phase III studies, with clinically meaningful separation from placebo on pain, sleep, and fatigue, show that fibromyalgia can be successfully treated by TNX 102 SL 5.6 mg and may provide the opportunity for Tonix to launch the first FDA-approved drug for fibromyalgia in more than a decade.”

“An estimated 6 million to 12 million adults in the U.S. are living with fibromyalgia, the majority of whom are women. We believe that these safety and efficacy results will be important to fibromyalgia patients who struggle not only with pain, but also multiple other symptoms and potential side effects from the currently approved pharmacotherapies,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Because fibromyalgia is a chronic condition with treatments intended to be used on a long-term basis, favorable tolerability and side effect profiles are integral to managing this debilitating condition and enhancing the quality of life for those suffering. We are now another important step closer to bringing a new first-line treatment to fibromyalgia patients that offers broad symptom relief with favorable tolerability attributes for chronic use and adherence.”