Tonix Pharmaceuticals Holding Corp. (TNXP) on Friday said it presented positive results from the Phase 3 RESILIENT study of TONMYA for fibromyalgia at the 2026 Non-Opioid Pain Therapeutics Summit on January 29 in Boston.
The study showed that fibromyalgia patients treated with sublingual TONMYA at bedtime achieved a statistically significant reduction in weekly average pain scores at Week 14 versus placebo, along with improvements in other symptoms including sleep disturbance and fatigue. TONMYA was well tolerated, with minimal impact on weight and blood pressure.
TONMYA was approved in August 2025, by the FDA for the treatment of fibromyalgia in adults.
"TONMYA'S sublingual formulation largely bypasses first-pass hepatic metabolism, which reduces formation of norcyclobenzaprine, the persistent active metabolite that we believe otherwise interferes with the duration of the treatment effect," said Chief Medical Officer, Gregory Sullivan.
Tonix shares closed down 0.38% at $18.22 on Thursday.
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