Fibromyalgia patients hoping to see a more effective and convenient formulation of cyclobenzaprine at their local pharmacies must wait for an ongoing phase III trial — the product’s third — to finish, as the first two delivered mixed results.
Findings from the positive RELIEF trial for the novel agent currently called TNX-102 (sublingual cyclobenzaprine) are now published, showing a significant reduction in pain scores compared with placebo. But this follows another phase III study called RALLY for which the developer, Tonix Pharmaceuticals, said the primary endpoint for pain relief was missed (and which has not been formally published).
To break the tie, Tonix is enrolling patients in RESILIENT, with a target of 470 patients and hopes of reporting topline results by the end of 2023.
Cyclobenzaprine in ordinary pill form has been suggested as a potential fibromyalgia pain reliever for decades, but rigorous studies have not demonstrated a clear benefit. A report prepared for the Agency for Healthcare Research and Quality in 2020 found mostly “no evidence” for pain relief in fibromyalgia.
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