Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Dr. Seth Lederman joined Steve Darling from Proactive to share additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL for the management of fibromyalgia. Dr. Lederman reported that the results from the study showed that TNX-102 SL treatment was not associated with increases in systolic or diastolic blood pressure or body weight.
Additionally, there were no reported sexual side effects. In fact, when systematically investigated using the Changes in Sexual Functioning Questionnaire short form, women who received the study drug had a higher CSFQ-14 score compared to those who received a placebo, indicating improved sexual function. These findings are significant for fibromyalgia patients who require long-term therapies, particularly since weight gain is associated with gabapentinoids, negative sexual side effects are linked to serotonin-reuptake inhibiting medications, and increased blood pressure is a concern with potent noradrenergic-reuptake inhibiting medications.
Dr. Lederman highlighted that Tonix Pharmaceuticals' work in this field may present an opportunity to launch the first FDA-approved drug for fibromyalgia in more than a decade. This news underscores the potential for TNX-102 SL to offer improved treatment options and quality of life for individuals suffering from fibromyalgia, a condition with limited therapeutic choices.