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 failed to reach their primary goal of significant pain reduction at the 2.8 mg dose after 12 weeks of treatment, and Tonix decided to discontinue its development for fibromyalgia and to focus on PTSD. Preliminary data from the Phase 3 PTSD trial (RECOVERY, NCT03841773) showed that a higher dose (2.8 mg twice daily for 5.6 mg total) had greater efficacy while retaining an acceptable safety and tolerability profile, the company announced in a press release. Working with the FDA, Tonix was given guidance Tonix for advancing TNX-102 SL as a potential fibromyalgia treatment at the 5.6 mg dose. “Initiating a new Phase 3 trial for TNX-102 SL
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