TNX-102 SL Candidate to Be Evaluated in Phase 3 Trial for Fibromyalgia

TNX-102 SL Candidate to Be Evaluated in Phase 3 Trial for Fibromyalgia
Tonix Pharmaceuticals is planning to expand the use of its investigational therapy TNX-102 SL, which is currently being explored as therapy for post-traumatic stress disorder (PTSD), for the treatment of people with fibromyalgia. The company is going to launch a Phase 3 clinical trial during which researchers will assess the safety and efficacy of 5.6 mg of TNX-102 SL (also known as Tonmya) in fibromyalgia patients. TNX-102 SL is a reformulation of the muscle relaxant compound cyclobenzaprine that was reinvented in the form of sublingual (under the tongue) tablets with analgesic properties. “We are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD," Seth Lederman, MD, president and CEO of Tonix, said in a news release. "We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation.” The therapeutic potential of TNX-102 SL has been previously studied in Phase 2 (BESTFIT, NCT01903265) and Phase 3 (AFFIRM, NCT02436096) trials in patients with fibromyalgia.  Results indicated the daily administration of TNX-102 SL at a 2.8 mg dosage could reduce patients’ pain, improve their sleep quality, and could also have beneficial effects on other fibromyalgia-related symptoms. Despite the positive effects, the company decided to stop the development of TNX-102 SL as a treatment for fibromyalgia and focus on its potential for PTSD treatment. Preliminary data of a Phase 3 trial (RECOVERY, NCT03841773) in people diagnosed with PTSD have suggested that when taken at a higher dose (2 x 2.8 mg daily), the treatment also had an analgesic
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