Tonix Reports Results of TNX-102 SL in P-III (RALLY) Study for the Treatment of Fibromyalgia
Shots:
- 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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
