Tonix Says Fibromyalgia Candidate Failed To Achieve Statistical Significance Over Placebo

Tonix Pharmaceuticals Holding Corp TNXP says that as expected, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) did not significantly reduce fibromyalgia daily pain at Week 14 compared to placebo in the Phase 3 RALLY study. 

• Tonix reported interim analysis results of RALLY in July 2021. The Independent Data Monitoring Committee recommended stopping the study as it was unlikely to succeed on the primary endpoint for the planned full sample. 
• Therefore, the Company stopped enrollment of new participants while continuing those enrolled at that time to completion.
• "The positive outcome of the earlier RELIEF study stands in contrast to the missed primary endpoint in RALLY," said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix. 
• Related: Tonix Pharma Fibromyalgia Treatment Associated with Improvement in Pain, Sleep, Fatigue.
• "We believe the difference between these study results may be largely driven by a 79% increase in adverse event-related participant discontinuations in the drug treatment group in RALLY compared to RELIEF. Similarly, a 77% increase of adverse event-related participant discontinuations was observed in the placebo group in RALLY compared to RELIEF," Sullivan added.
• Price Action: TNXP shares are down 3.08% at $0.23 during the market session on the last check Monday.