Tonix Pharmaceuticals Reports the US FDA’s NDA Acceptance of TNX-102 SL for Treating Fibromyalgia
Shots:
- The US FDA has accepted the NDA of non-opioid, centrally-acting analgesic, TNX-102 (cyclobenzaprine HCl sublingual tablets), for treating fibromyalgia with the decision anticipated on Aug 15, 2025
- The NDA was based on 2 P-III (RELIEF & RESILIENT) clinical studies assessing safety and efficacy of TNX-102 SL (5.6mg) vs PBO as a bedtime treatment for fibromyalgia, for 14wks.
- Both the RELIEF & RESILIENT trials, completed in Dec 2020 & 2023 respectively, achieved the 1EPs of significant pain reduction. The drug was well tolerated with no new concerns & most common TEAEs being tongue or mouth numbness at the administration site; systemic AE rates were below 4% (excl. COVID-19)
Ref: Tonix Pharmaceuticals | Image: Tonix Pharmaceuticals
Related News:- Tonix Pharmaceuticals Reports the Results for TNX-102 SL in P-III Trial for the Management of Fibromyalgia
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
