Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biotech company, earlier announced that in the Phase 3 RELIEF trial, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) reached its pre-specified primary endpoint, substantially reducing everyday pain in fibromyalgia participants relative to placebo (p=001) (Table 1). (Table 1). TNX-102 SL is a modern non-opioid, centrally-acting analgesic that has been formulated for the treatment of Fibromyalgia and is taken once daily at bedtime. RELIEF was a 14-week TNX-102 SL 5.6 mg randomized, double-blind, placebo-controlled study in which a total of 503 patients with Fibromyalgia were randomized through 39 U.S. sites with a 1:1 ratio.
For the first two weeks, all patients obtained one tablet of TNX-102 SL (2.8 mg) or placebo, which was improved for the remaining 12 weeks to 2 tablets of TNX-102 SL (5.6 mg) or placebo.
Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, said, “Tonix is focused to improving the quality of life of the millions who suffer from fibromyalgia, about 90% of which are women, and the results of the RELIEF trial bringing fresh hope to this group.”
At 5.6 mg, TNX-102 SL demonstrated highly significant and strongly positive progress in the primary endpoint of daily pain reduction and activity in the key secondary endpoints of sleep improvement and fatigue reduction. Finding a dose that balances safety and tolerability is one of the greatest challenges in clinical trials. In the RELIEF study, the company gladly found the consistent effects of TNX-102 SL 5.6 mg on both the primary endpoint of daily pain and the tolerability of this dose.