Tonix Pharma Starts New Pivotal Trial For TNX-102 SL In Fibromyalgia Patients

Tonix Pharmaceuticals Holding Corp TNXP has enrolled the first patient in the new Phase 3 RESILIENT study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.

• An interim analysis by an Independent Data Monitoring Committee of the first 50% of enrolled patients for a potential sample size readjustment or early stop for futility is expected in Q1 of 2023.
• In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg to manage fibromyalgia.
• Several secondary measures in RELIEF highlighted the broad effects of TNX-102 SL across several cardinal symptoms of fibromyalgia beyond pain. 
• In March 2022, Tonix reported the results of a subsequent Phase 3 study (RALLY) in which TNX-102 SL did not achieve statistical significance on the primary endpoint (p=0.115). 
• Relative to the RELIEF study, RALLY had an unexpected increase in study participant adverse event-related discontinuations in both the drug and placebo groups.
• Fibromyalgia is a pain disorder characterized by chronic widespread pain, non-restorative sleep, fatigue, and impaired cognition.
• Price Action: TNXP shares are up 7.48% at $0.23 during the market session on the last check Thursday.