Tonix Pharmaceuticals Holding Corp (TNXP)

[Value_Investor]

Great news for TNXP today --- see the link below! But very stupid CEO issued good news before 9:30 AM again --- at 7:31 AM!

http://ih.advfn.com/p.php?pid=nmona&article=74087311

Tonix Pharmaceuticals Receives Notice of Allowance for New U.S. Patent Covering Composition and Manufacture of TNX-102 SL

Tonix Pharmaceuticals Holding (NASDAQ:TNXP)

Today : Tuesday 14 March 2017

Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced today that the U.S. Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application 14/214,433, “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride,” covering the proprietary sublingual formulation of TNX-102 SL*. A Notice of Allowance signifies that Tonix will be entitled to receive patent protection until 2034 in the U.S. for the allowed claims when the patent is issued. Tonix expects the patent to be issued within two months.

The allowed claims protect the pharmaceutical composition and the method of manufacturing of TNX-102 SL. The TNX-102 SL sublingual formulation is based on a eutectic between cyclobenzaprine HCl and mannitol, which protects the acidic hydrochloride salt of cyclobenzaprine from molecular interactions with the basic excipient, potassium phosphate dibasic, which is added to enhance transmucosal absorption. Transmucosal absorption of cyclobenzaprine increases the rate of absorption into the blood stream and bypasses first pass liver metabolism. TNX-102 SL is distinct from orally ingested forms of cyclobenzaprine, which are available as generic immediate-release tablets and branded extended-release capsules (AMRIX®), and are approved for short-term use (2-3 weeks) for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Since TNX-102 SL has a different route of administration and different pharmacokinetic profile from orally ingested cyclobenzaprine and is intended for a new indication (PTSD), pharmacists will not be able to substitute orally ingested forms of cyclobenzaprine for TNX-102 SL.

Tonix has filed trademarks to describe the protective eutectic, Protectic™, and the formulation that utilizes interactions at the angstrom scale, Angstro-Technology™. The Protectic™ protective eutectic and Angstro-Technology™ formulation enable TNX-102 SL to be a sublingual tablet of cyclobenzaprine HCl, while ensuring that the tablets have robust manufacturability and pharmaceutical stability.

Seth Lederman, M.D., president and chief executive officer of Tonix, stated, “This notice of allowance strengthens the value of our pipeline with near-term intellectual property protection and highlights Tonix’s innovation in proprietary pharmaceutical development. Most importantly, the Protectic™ protective eutectic and Angstro-Technology™ formulation are essential elements of the proprietary TNX-102 SL composition.”

*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.