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Tonix Pharmaceuticals Announces Issuance of U.S. Patent for Crystalline Tianeptine Oxalate Salt, the Active Ingredient of TNX-601
NEW YORK, Oct. 23, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"NEW YORK, Oct. 23, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (\"USPTO\") issued U.S. Patent No. 10,449,203 to the Company on October 22, 2019. This patent, “Tianeptine Oxalate Salts and Polymorphs,” includes claims directed to crystalline tianeptine oxalate salts, and disclosures directed to methods of using those crystalline forms and their compositions. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until December 28, 2037.\n Tonix’s novel oral formulation of one of the claimed tianeptine oxalate salts, or TNX-601, is being developed as a potential treatment for posttraumatic stress disorder (PTSD) and also as a potential treatment for neurocognitive dysfunction associated with corticosteroid use. Tianeptine modulates the glutamatergic system indirectly and reverses the neuroplastic changes that are observed during periods of stress and corticosteroid use. Tianeptine is a weak mu-opioid receptor agonist, but does not have significant affinity for other known neurotransmitter receptors. Currently there is no tianeptine-containing product approved in the U.S., though tianeptine sodium (amorphous) has been available in Europe, Asia, and Latin America for the treatment of depression since 1987. TNX-601 is designed for daytime dosing and may provide improved stability, consistency, and manufacturability as compared to the amorphous sodium salt. TNX-601 is being developed under Section 505(b)(1) of the Federal Food, Drug and Cosmetic Act (FDCA). About Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Tonix’s lead product candidate, TNX-102 SL*, is in development for posttraumatic stress disorder (PTSD), fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder (AUD). TNX-102 SL is in Phase 3 development as a bedtime treatment for PTSD (trade name Tonmya**) and fibromyalgia, with topline data in PTSD expected in the first half of 2020. The agitation in Alzheimer’s disease program is Phase 2 ready and the development for AUD is in the pre-Inv...