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. 
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One comment

  1. Sue says:

    This winter with drastic weather B . pressure level changes has been hell. Is anyone else with Fibro. experiencing this also. On sunny days the awful pain subsides but when cloudy and rain it’s hell.

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