Tonix Pharma Reports Positive Pre-NDA CMC Meeting with FDA for Tonmya™ in Fibromyalgia Management

Tonix Pharmaceuticals, Inc., a fully-integrated biopharmaceutical company, has announced the receipt of formal minutes from a recent pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding their drug candidate, Tonmya™, aimed at managing fibromyalgia. The meeting's goal was to achieve consensus and approval from the FDA on critical CMC issues essential for the planned NDA submission for Tonmya. The company believes it has achieved alignment with the FDA on crucial components, such as proposed drug substance and product commercial specifications, shelf life assignment, and manufacturing and commercial packaging strategies.

Additionally, Tonix Pharmaceuticals has completed its second and final pre-NDA meeting with the FDA, focusing on nonclinical, clinical pharmacology, and clinical matters. While awaiting formal minutes from this meeting, the company is optimistic about the outcomes and remains on schedule to submit the NDA for Tonmya in the second half of 2024.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, expressed his optimism about bringing a new treatment for fibromyalgia to market, a condition that has not seen new therapeutic options for over a decade. He emphasized the importance of the FDA's guidance during the pre-NDA CMC meeting, which confirmed alignment on CMC content and commercial strategy for Tonmya. The company is actively preparing for a dual manufacturing launch strategy in collaboration with global contract development and manufacturing organizations (CDMO), including Almac Pharma Services.

Fibromyalgia is a chronic pain disorder that amplifies sensory and pain signals within the central nervous system, affecting an estimated 6 million to 12 million adults in the U.S., predominantly women. Symptoms include chronic widespread pain, nonrestorative sleep, fatigue, morning stiffness, cognitive dysfunction, mood disturbances, anxiety, and depression. Current treatments often leave patients dissatisfied, highlighting the need for new therapeutic options.

Tonmya, also known as TNX-102 SL, is a non-opioid, non-addictive bedtime medication developed specifically for fibromyalgia management. It is a patented sublingual formulation of cyclobenzaprine hydrochloride. In December 2023, Tonix reported significant results from the RESILIENT study, the second pivotal Phase 3 clinical trial for Tonmya. The study showed that Tonmya significantly reduced daily pain compared to placebo, meeting its primary endpoint. Additionally, it demonstrated statistically significant and clinically meaningful results in six key secondary endpoints, including improvements in sleep quality, fatigue reduction, and overall fibromyalgia symptoms and function. The first Phase 3 trial, RELIEF, completed in December 2020, also met its primary endpoint of daily pain reduction compared to placebo and showed efficacy in key secondary endpoints.

Tonix Pharmaceuticals is dedicated to developing, licensing, and commercializing therapeutics to treat and prevent human diseases, with a particular focus on central nervous system (CNS) disorders. The company prioritizes submitting the NDA for Tonmya in 2024, following two successful Phase 3 studies for fibromyalgia management. Additionally, TNX-102 SL is under development for treating acute stress reactions and fibromyalgia-type long COVID. The CNS portfolio also includes TNX-1300 (cocaine esterase) for cocaine intoxication, supported by the National Institute of Drug Abuse, and TNX-1500, a humanized monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases. Tonix’s development efforts extend to rare and infectious diseases as well.

Overall, Tonix Pharmaceuticals is poised to make significant contributions to fibromyalgia treatment and other CNS disorders, with an active pipeline and strategic collaborations aimed at bringing new therapeutic options to market.