Tonix Pharmaceuticals (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, is reporting positive results from its clinical pharmacokinetic (“PK”) bridging study of Tonmya(TM). The study evaluated the efficacy of Tonmya, also known as TNX-102 SL (cyclobenzaprine HCl sublingual tablets), in healthy adult male and female ethnic Japanese and Chinese volunteers. The report noted that Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.”
“This bridging study is an important first step as we begin evaluating the potential for approval and marketing Tonmya in Japan and China,” said Tonix Pharmaceuticals CEO Seth Lederman, MD, in the press release. “The results show a similar pharmacokinetic profile in ethnic Japanese and Chinese volunteers with a Caucasian comparator group. As a result, we believe that these data, with supporting results recently reported from the positive phase 3 RESILIENT study, are the only clinical data needed to support regulatory filings in Japan and China.”
To view the full press release, visit https://nnw.fm/1iRgl
About Tonix Pharmaceuticals Holding Corp.
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya, a product candidate for which two positive phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ-transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (“CD40L” or “CD154”) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R) (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about the company, please visit www.TonixPharma.com.
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