Tonix Pharmaceuticals (NASDAQ:TNXP) presented a poster at the 5th International Congress on Controversies in Fibromyalgia in Vienna that its TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain, compared with placebo in participants with fibromyalgia.
When the primary endpoint was analyzed as a greater than or equal to 30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%).
TNX-102 SL also at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery.
In addition, TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and only lead to one discontinuation.
“We are looking forward to the results of a planned interim analysis due next quarter for our RESILIENT study, a potentially pivotal confirmatory Phase 3 study of TNX-102 SL for the management of fibromyalgia,” Seth Lederman, M.D., said in a statement.
