On October 16, 2024, Tonix Pharmaceuticals Holding Corp. (TNXP) announced that it submitted the New Drug Application (NDA) for TNX-102 SL for the treatment of fibromyalgia. The NDA is supported by the results of two Phase 3 clinical trials that reported statistically significant results on the primary endpoint of reducing widespread pain. The FDA typically has a 60-day filing review period to determine whether the submitted NDA is acceptable for review. If accepted for review, the FDA should assign a Prescription Drug User Fee Act (PDUFA) date for an approval decision in August 2025 for standard review or April 2025 if granted priority review.
