TNX-102 SL Holds Potential to Treat FM Symptoms, Phase 3 Trial Data Show

TNX-102 SL Holds Potential to Treat FM Symptoms, Phase 3 Trial Data Show
The investigational therapy TNX-102 SL (sublingual cyclobenzaprine) had significant beneficial impact on sleep quality and fatigue, although it did not reduce pain levels in patients with fibromyalgia, results from a Phase 3 trial show. Although these results were disappointing in terms of pain reduction, the trial still demonstrated that TNX-102 SL can have a broad effect on several symptoms related to fibromyalgia. Supported by these preliminary results and by data from previous studies on people with post-traumatic stress disorder, researchers are planning a new Phase 3 trial to further explore the therapeutic potential of higher doses of TNX-102 SL as treatment for fibromyalgia. The latest results of the Phase 3 AFFIRM study were recently discussed at the 2019 ACR/ARP Annual Meeting held in Atlanta, in the oral presentation “A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) for the Treatment of Fibromyalgia (FM): Evidence for a Broad Spectrum of Activity on the FM Syndrome.” Current oral cyclobenzaprine-based therapies are mainly limited to short-term use of two to three weeks and are used to relieve muscle spasms and pain or injury. TNX-102 SL is a new formulation
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