Tonix Ends Drug’s Trial on Fibromyalgia, Refocuses on PTSD

Tonix Pharmaceuticals’ Phase III clinical trial evaluating TNX-102 SL in fibromyalgia patients did not meet its primary efficacy endpoint. The company plans to halt development in this indication and refocus the program on treating post-traumatic stress disorder.

Preliminary topline results from the double-blind trial, named AFFIRM, did not demonstrate a statistically significant difference in the proportion of patients that reported a 30 percent or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis.

AFFIRM was a placebo-controlled trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken daily at bedtime, in which 519 participants were enrolled at 35 U.S. centers.