TNX-102 Helps Ease Fibromyalgia Pain, Fatigue, Data Show

TNX-102 Helps Ease Fibromyalgia Pain, Fatigue, Data Show
Tonix Pharmaceuticals’ investigational therapy TNX-102 SL (sublingual cyclobenzaprine) safely and effectively eased pain and fatigue in people with fibromyalgia, while also improving their sleep, according to top-line data from the RELIEF Phase 3 trial. The therapy, given at a dose of 5.6 mg every night at bedtime, met the trial’s main goal and most of its secondary goals, supporting the treatment's beneficial effects in a patient population with a high unmet need for effective treatments. “Tonix is dedicated to improving the lives of the millions suffering from fibromyalgia, approximately 90% of whom are female, and the results of the RELIEF trial bring new hope to this community,” Seth Lederman, MD, Tonix’s president and CEO, said in a press release. “One of the biggest challenges in drug development is finding a dose that balances efficacy and tolerability,” he said, adding that Tonix is pleased with the therapy's consistent effects on pain and the tolerability of the dose studied. Gregory Sullivan, MD, Tonix’s chief medical officer, said that “TNX-102 SL could potentially offer fibromyalgia patients, who have multiple disabling fibromyalgia symptoms, a first-line [single therapy] with broad symptom relief, and the compliance advantage of being administered once-a-day (at bedtime).” The therapy’s active ingredient, cyclobenzaprine, “has no recognized potential for addiction,” he added, in contrast to opioids, which are used by about one-third of fibromyalgia patients “out of desperation and because of dissatisfaction with available therapies.” A second potential pivotal Phase 3 study, called RALLY (NCT04508621), designed to test a higher dose of TNX-102 SL, is currently enrolling people with fibromyalgia, and top-line d
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