Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has announced a second major managed Medicare agreement for TONMYA® (cyclobenzaprine HCl sublingual tablets), its newly approved treatment for fibromyalgia in adults. The agreement, effective immediately, adds approximately 21 million Medicare lives, bringing total Medicare coverage to approximately 32 million lives, or 58% of the approximately 55 million Medicare lives in the United States. This expansion marks a significant milestone for the company as it seeks to establish TONMYA as a leading therapy in a market that has seen no new treatment options in more than 15 years.
The impact of this agreement extends beyond Medicare. With the addition of this managed Medicare contract, total commercial and government payer coverage for TONMYA now reaches approximately 166 million covered lives, representing 53% of the approximately 314 million total U.S. lives. This broad coverage is critical for ensuring that patients with fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, and cognitive difficulties, can access the first new treatment approved for the condition in over a decade. The company previously announced commercial payer agreements with two leading group purchasing organizations and one major managed Medicare agreement, while TONMYA is also covered by Medicaid in nearly all states.
To support the launch and ongoing commercialization of TONMYA, Tonix has activated approximately 50 new sales representatives in the field, bringing its total sales force to 150 representatives. This expanded team is expected to drive awareness and adoption among healthcare providers, further solidifying the product's market presence. For investors and industry observers, the rapid scaling of payer coverage and sales infrastructure underscores Tonix's commitment to maximizing the potential of its flagship medicine. The company's CNS commercial infrastructure also supports its acute migraine products, Zembrace® SymTouch® and Tosymra®, and is designed to leverage synergies across its portfolio.
Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. Beyond TONMYA, the company is advancing a pipeline of innovative therapies, including TNX-2900 for Prader-Willi syndrome, TNX-4800 for Lyme disease prophylaxis, and TNX-1500 for the prevention of kidney transplant rejection. TONMYA is also being evaluated in Phase 2 clinical trials for major depressive disorder and acute stress disorder, which could further expand its label and patient reach if successful. However, these product development candidates are investigational new drugs or biologics, and their efficacy and safety have not been established or approved for any indication.
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