Tonix Pharmaceuticals Holding Corp (Nasdaq: TNXP) has announced highly statistically-significant and clinically-meaningful top-line results in a second positive Phase III trial of TNX-102 SL for the management of fibromyalgia.
The RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo, and there were significant improvements on all secondary endpoints, including patient global impression, fibromyalgia-specific symptoms and dysfunction, fatigue and sleep measures.
"We are now an important step closer to bringing a new, first-line treatment to fibromyalgia patients"These results support the US biopharma’s planned New Drug Application (NDA) filing to the US Food and Drug Administration (FDA) in the second half of 2024, adding to data from three years ago.
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