New Phase 3 Trial of Non-opioid Pain Relief Tablet to Open in US, Tonix Says

New Phase 3 Trial of Non-opioid Pain Relief Tablet to Open in US, Tonix Says
Tonix Pharmaceuticals announced it is opening a new Phase 3 trial to evaluate the efficacy and safety of its investigational therapy TNX-102 SL, a sublingual tablet, in easing the widespread pain linked to fibromyalgia. Called RELIEF (NCT04172831) and taking place at sites across the U.S., the study is expected to enroll a first patient by year's end. TNX-102 SL is a non-opioid, non-addictive analgesic that acts on the central nervous system to decrease pain. It is a reformulation of the muscle relaxant compound cyclobenzaprine in a sublingual (under-the-tongue) form. Should TNX-102 SL  be approved by the U.S. Food and Drug Administration (FDA), it will be available under the brand name Tonmya. The therapy is currently in Phase 2 trials for agitation in Alzheimer’s disease, and a Phase 3 study for post-traumatic stress disorder (PTSD). The company previously tested TNX-102 SL in a Phase 2 (BESTFIT, NCT01903265) and Phase 3 (AFFIRM, NCT02436096) trial in fibromyalgia patients. Results indicated daily use at a 2.8 mg dosage helped to reduce patients’ pain and improve sleep quality. But both studies
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