Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced a major managed Medicare agreement for TONMYA (cyclobenzaprine HCl sublingual tablets), adding approximately 9 million Medicare beneficiaries effective Jan. 1, 2027. Combined with previously announced commercial coverage agreements and broad Medicaid availability, the company said TONMYA will have pharmacy coverage reaching approximately 145 million covered lives, or 46% of the U.S. covered market, while discussions with additional commercial and Medicare payers continue.
Following the expanded coverage and positive launch metrics, Tonix plans to add 50 sales representatives by mid-third quarter 2026, increasing its commercial sales force to approximately 150 people. The company said it is also expanding marketing and medical affairs initiatives to increase awareness of TONMYA as a first-in-class, non-opioid treatment option for fibromyalgia. The full press release is available at https://ibn.fm/tVAj3.
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. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), the company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra.
Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
The expansion of Medicare coverage for TONMYA is significant because it provides access to a non-opioid treatment option for fibromyalgia patients, addressing a high unmet medical need. With 145 million covered lives, Tonix is well-positioned to capture a substantial share of the fibromyalgia market. The company’s decision to increase its sales force and marketing efforts underscores its commitment to driving adoption of TONMYA. The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP.
Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
