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Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, announced that the European Patent Office (“EPO”) issued European Patent No. 2968992 to the Company on December 11, 2019. This patent, “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Mannitol,” includes 14 claims directed to compositions comprising eutectics of cyclobenzaprine hydrochloride and mannitol and methods of making those compositions. This patent is expected to provide Tonix with market exclusivity until 2034.
Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, “The issuance of this European patent is an important step forward in our efforts to broaden our intellectual property estate on a global basis for TNX-102 SL*.”
Tonix’s proprietary eutectic formulation of cyclobenzaprine, or TNX-102 SL, is designed for chronic sublingual (under-the-tongue) administration daily at bedtime, which the Company believes facilitates transmucosal absorption of cyclobenzaprine and bypasses first-pass liver metabolism. Marketed cyclobenzaprine drug products are limited to short-term use (two to three weeks) and formulated for oral ingestion, which results in significant liver metabolism. Sublingual TNX-102 SL has a different pharmacokinetic profile than marketed oral cyclobenzaprine drug products. TNX-102 SL is being developed as a treatment for four indications: posttraumatic stress disorder (PTSD), fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder. Marketed oral cyclobenzaprine products are indicated for the relief of muscle spasm.
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