Tonix Pharmaceuticals Gets FDA Nod to Advance Fibromyalgia Treatment

Shares in biopharmaceutical company, Tonix Pharmaceuticals (Nasdaq: TNXP), climbed on Thursday morning after the company announced that it had successfully completed a positive pre-NDA Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA. Based on formal written feedback, Tonix believes it is aligned with the FDA on key topics, including proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging.

Tonix remains on track to submit its NDA for Tonmya™, centrally acting, non-opioid, non-addictive, bedtime medication for the management of fibromyalgia to the FDA in the second half of 2024.

Commenting on the news, Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, said “We remain encouraged and excited about the prospect of bringing the first new treatment to market for fibromyalgia patients in over a decade, and this encouraging meeting with the FDA is an important milestone as we head into the final stages of completion of the NDA package.

“During the pre-NDA CMC meeting, the FDA affirmed alignment with Tonix on CMC content and commercial strategy for Tonmya, and we are very appreciative of the FDA’s guidance as we prepare for our NDA submission. We are currently actively preparing a dual manufacturing launch strategy with global contract development and manufacturing organization (CDMO) Almac Pharma Services and another CDMO.”

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. It affects an estimated 6 million to 12 million adults in the US.

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 FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant 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 that has FDA Breakthrough Therapy designation that is in Phase 2 development and is supported by a grant from the National Institute of Drug Abuse. 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, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. Further information about Tonix can be found at www.tonixpharma.com.