Phase 3 Trial of Bedtime Treatment, TNX-102 SL, Reaches Half Enrollment

Phase 3 Trial of Bedtime Treatment, TNX-102 SL, Reaches Half Enrollment
The RELIEF Phase 3 trial assessing the safety and efficacy of TNX-102 SL (sublingual cyclobenzaprine) as a nighttime treatment of pain and disturbed sleep due to fibromyalgia has reached half of its planned enrollment of patients, Tonix Pharmaceuticals announced. Tonix anticipates sharing early treatment results in this first group of patients in September, but acknowledged that the COVID-19 pandemic may delay data monitoring and analysis. The muscle relaxant cyclobenzaprine has the potential to block different receptors involved in pain, sleep, and stress regulation, being a promising approach to ease symptoms of fibromyalgia. Current oral formulations, however, are limited to short-term use due to liver toxicity, and exposure to active compounds that may result as cyclobenzaprine breaks down in the body. TNX-102 SL is a reformulation of cyclobenzaprine, taken as sublingual (under the tongue) tablets. Tonix reports this formulation not only helps the active ingredient reach the bloodstream faster, but also results in limited toxicity to the liver, suggesting it can be used for longer periods. The therapy was evaluated in a prior Phase 3 trial, named AFFIRM (NCT02436096), in 519 people with fibromyalgia. Enrolled across 35 sites in the U.S., participants were randomly assigned to either a 2.8 mg dose of TNX-102 SL tablets, or a placebo, given daily at bedtime for 12 weeks
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