Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced a new European patent for composition and formulation of TNX-102 SL. The patent will provide the company with market exclusivity until 2034.
The New York-based Tonix says the 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.
CEO Seth Lederman 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.
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.
Shares in Tonix ballooned 31 cents, or 31.4%, to $1.28.