Tonix Reports Results of TNX-102 SL in P-III (RALLY) Study for the Treatment of Fibromyalgia
- The P-III (RALLY) study evaluates TNX-102 SL (5.6mg) vs PBO in a ratio (1:1) in 514 patients with FM across 36 US sites. The trail failed to achieve statistical significance on the 1EPs of reducing FM daily pain @14wk., based on interim analysis as reported in July 2021
- The results also showed nominal significance on the PROMIS sleep disturbance measure & proportion of responders (29.7% vs 21.7%) while other key 2EPs did not achieve nominal significance, was well tolerated with no new safety signals
- Additionally, 73.8% & 81.4% has completed 14wk. dosing period & study had an unexpected increase of AEs-related discontinuations. The company plans to initiate P-III (RESILIENT) study in H1’22
Ref: Tonix | Image: Tonix
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