Tonix Pharmaceuticals Holding Corp. announced receipt of the 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) for Tonmya for the management of fibromyalgia. The purpose of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support a planned NDA submission for Tonmya for the management of fibromy arthritis.

Based on formal written feedback, the Company 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. In addition, the Company has completed the second and final pre-NDA meeting for Tonmya with the FDA and discussed nonclinical, clinical pharmacology and clinical matters. The Company awaits formal minutes after which it expects to announce the results of that meeting.

The Company remains on track to submit the NDA for Tonmya for the Management of fibromyalgia to the FDA in the second half of 2024. Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women.

Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.

Physicians and patients report common dissatisfaction with currently marketed products. Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia.

In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function.

RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.