Tonix Pharmaceuticals announced the presentation of additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL for the management of fibromyalgia, at Biotech Showcase 2024 in San Francisco, January 8-10. As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo 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 to the U.S. Food and Drug Administration in the second half of 2024 for TNX-102 SL for the management of fibromyalgia. RELIEF, the first Phase 3 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 and showed activity in key secondary endpoints.
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