CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, has announced the selection of two contract manufacturing organizations (CMOs), including Almac Pharma Services, to prepare for the potential commercial launch of Tonmya™, a non-opioid analgesic aimed at treating fibromyalgia.
The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024.
Tonmya™, also known as TNX-102 SL, is a sublingual tablet containing cyclobenzaprine HCl intended to be taken at bedtime. It has demonstrated positive results in two Phase 3 studies, with the most recent study, RESILIENT, achieving its primary endpoint by significantly reducing daily pain compared to placebo. The medication also showed statistically significant improvements in sleep quality, fatigue, and overall symptoms related to fibromyalgia.
The drug is designed for chronic, long-term use, with a dosing regimen that starts with one tablet daily, increasing to two tablets as tolerated. The sublingual delivery system is formulated to enhance stability and allow for rapid systemic exposure. Tonix's CEO, Seth Lederman, M.D., expressed confidence in the dual sourcing strategy for the launch and supply chain management of Tonmya™.
Tonmya™'s development has been part of Tonix's focus on central nervous system (CNS) disorders, including acute stress reaction and fibromyalgia-type Long COVID. The company's portfolio also includes other CNS and immunology development projects.
Almac Pharma Services, with over 50 years of experience, offers pharmaceutical development and commercial solutions. The company recently expanded its commercial manufacturing and packaging capabilities as part of a global investment.
Tonix has emphasized that TNX-102 SL is still an investigational drug and has not yet been approved for any indication. The information presented in this article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.