Tonix Pharmaceuticals Reports the Results for TNX-102 SL in P-III Trial for the Management of Fibromyalgia
Shots:
- The P-III (RESILIENT) study evaluates the safety & efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets; 5.6mg) vs PBO on fibromyalgia patients (n=457) across 33 sites in the US for 12wks
- The 1EP of the study includes daily diary pain severity score change from baseline to 14wks. examined by mixed model repeated measures with multiple imputations. Additionally, the study's preliminary unaudited AE-related discontinuation rate of 4.8% indicated a higher level of improvement than the rates of 6.0% & 0.7% in the P-III trials (RELIEF) & (RALLY) trials
- Moreover, the results from the trials are expected by YE 2023 based on which the company expects to submit an NDA to the US FDA
Ref: Tonix Pharmaceuticals | Image: Tonix Pharmaceuticals
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
