Shots:
- The US FDA has approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults; commercially available in Q4’25
- Approval was based on 2 P-III (RELIEF & RESILIENT) trial assessing Tonmya vs PBO in 503 & 457 pts, respectively in the US, where pts started on Tonmya 2.8mg & increased the dose to 5.6mg for the remaining 12wks.
- Both trials showed reduced daily pain scores (1EP) at 14wks. & higher proportion of pts experiencing significant improvement (≥30%) in pain after 3mos.; RESILIENT data was published in Pain Medicine
Ref: Tonix Pharmaceuticals | Image: Tonix Pharmaceuticals | Press Release
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