Summary by Moomoo AI
On February 13, 2024, Tonix Pharmaceuticals Holding Corp. announced the engagement of Rho, Inc., a contract research organization, to assist with the preparation and planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tonmya™, a product candidate for the management of fibromyalgia. The announcement was made through a press release filed with the SEC as part of a Form 8-K report. Tonmya™, which is a sublingual tablet formulation of cyclobenzaprine hydrochloride, has shown statistically significant results in two Phase 3 trials. The company plans to meet with the FDA in the first half of 2024 and aims to submit the NDA in the second half of the year. Fibromyalgia, a chronic pain condition, affects approximately 10 million U.S. adults and is characterized by widespread pain, nonrestorative sleep, fatigue, and other symptoms. Current treatments often leave patients and physicians dissatisfied, highlighting the need for new therapeutic options. Tonix Pharmaceuticals is focused on central nervous system disorders and has a portfolio of development candidates in addition to Tonmya™.