Positive efficacy and safety data from phase III RELIEF study of TNX 102 SL for the management of fibromyalgia at the congress on controversies in fibromyalgia
TNX 102 SL from Tonix Pharmaceuticals met its pre-specified primary endpoint in the Phase III RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia
Also, when the primary endpoint was analyzed as a greater than 30% pain responder analysis, there was a higher rate of responders to TNX 102 SL (47%) than to placebo (35%; p=0.006). TNX 102 SL 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.
Early discontinuation rates were similar for TNX 102 SL and placebo (17.7% and 16.5%, respectively). 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.
"There continues to be a pressing need for new, safe and more tolerable drugs to treat patients with fibromyalgia,” said Dr. Lederman. “We are looking forward to the results of a planned interim analysis due next quarter for our RESILIENT study, a potentially pivotal confirmatory Phase III study of TNX 102 SL for the management of fibromyalgia.”
In addition to the presentation, the Company’s submitted abstract will be published in an online supplement to the journal Clinical and Experimental Rheumatology in a special issue on Fibromyalgia.
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