Tonix Reports the First Patient Enrollment in the P-III (RESILIENT) Study of TNX-102 SL for the Management of Fibromyalgia
Shots:
- The first patient has been enrolled in the P-III (RESILIENT) study to evaluate the efficacy & safety of TNX-102 SL1 (5.6mg) vs PBO in 470 patients with fibromyalgia across the US
- The 1EPs of the study is the daily diary pain severity score change from baseline to 14wk. as analyzed by mixed model repeated measures with multiple imputations while an interim analysis results of the first 50% enrolled patients for a sample size readjustment or early stop for futility are expected in Q1'23
- The results from the (RESILIENT) study & P-III (RELIEF) study will support the NDA submission. The P-III (RALLY) study of TNX-102 SL failed to achieve statistical significance on the 1EPs
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.
