Tonix Receives US Patent for Investigational Therapy TNX-102 SL to Treat Fibromyalgia

Tonix Receives US Patent for Investigational Therapy TNX-102 SL to Treat Fibromyalgia
Tonix Pharmaceuticals has been granted a U.S. patent for its investigational therapy TNX-102 SL (cyclobenzaprine HCl sublingual tablets), designed to treat fibromyalgia, among other indications. Issued by the U.S. Patent and Trademark Office under the title “Eutectic Formulations of Cyclobenzaprine Hydrochloride,” the patent includes claims about the pharmaceutical composition and manufacturing of the eutectics in TNX-102 SL. Eutectic refers to a mixture of substances that melt and freeze at the same temperature. The therapy — for the treatment of fibromyalgia (FM), post-traumatic stress disorder (PTSD), and agitation in Alzheimer’s disease — remains under patent law until 2035, giving Tonix market exclusivity in the United States until then. TNX-102 SL is a proprietary under-the-tongue (or sublingual) eutectic formulation of cyclobenzaprine. The medicine inhibits different receptors that are involved in pain, sleep, and stress, including the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors. The therapy was designed to deliver a small dose of cyclobenzaprine to the bloodstream without it being metabolized in the liver, which can otherwise greatly decrease the concentration of the medicine. Furthermore, the formulation decreases the body's exposure to an active breakdown product known as norcyclobenzaprine, which has a long half-life in blood plasma. In contrast, currently marketed cyclobenzaprine-based therapies are oral therapies, which means that they undergo high levels of liver metabolism. They are mainly limited to short-term use of two to three weeks and are used to treat muscle spasm relief. However, TNX-102 SL has a different pharmacokinetic profile — what the body does to a therapy — compared with current cyclobenzapr
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