other material
confidence high
sentiment positive
materiality 0.65
Tonix unveils post hoc data: TONMYA pain relief from Day 2; NNT=7, NNH=26
Tonix Pharmaceuticals Holding Corp.
- Post hoc analysis of Phase 3 RESILIENT trial (n=457) shows TONMYA pain improvement vs placebo from Day 2, significant through Week 14 (p<0.001).
- Primary endpoint met with LS mean treatment difference of -0.65 in weekly pain score; all key secondary endpoints significant.
- Pooled analysis (n=959) reports NNT for ≥30% pain reduction at Week 14 = 7 (95% CI 5-12); NNH for discontinuation = 26 (95% CI 14-110).
- LHH = 3.7, indicating nearly 4-fold greater likelihood of clinical benefit vs adverse event-related discontinuation.
- TONMYA launched in November 2025 as first fibromyalgia approval in 15 years; mild transient oral hypoesthesia and dysgeusia most common adverse events.