Tonix Pharmaceuticals Expands Medicare Coverage for TONMYA®
Tonix Pharmaceuticals, a biotechnology firm headquartered in Berkeley Heights, N.J., has announced a major expansion of coverage for its drug TONMYA® (cyclobenzaprine HCl sublingual tablets). Starting January 1, 2027, under a new managed Medicare agreement, access will extend to approximately 9 million Medicare beneficiaries, covering about 16% of the U.S. Medicare population. This substantial coverage expansion complements ongoing partnerships with major commercial group purchasing organizations, broadening reach to roughly 145 million people, translating to 46% of the U.S. insured population. Tonix plans to grow its sales force by adding 50 representatives, aiming for a total of 150 by mid-2026 to optimize market penetration.
Seth Lederman, M.D., President and CEO, emphasized the strategic importance of expanded Medicare access, aligning with successful engagements within commercial sectors to fulfill growing patient demand for fibromyalgia treatments. Thomas Englese, MBA, Executive Vice President, highlighted the positive reception among healthcare providers and the significance of increasing outreach through an enlarged sales team. TONMYA, FDA-approved in 2025 as the first novel prescription for fibromyalgia in over 15 years, offers a non-opioid alternative with rapid absorption through its sublingual tablet formulation and holds U.S. patent protections until 2034, ensuring market exclusivity.
Tonix is actively exploring additional therapeutic areas like major depressive disorder and acute stress disorder, leveraging proprietary technology. The company's robust research extends into infectious diseases and rare disorders, reflecting a commitment to therapeutic innovation. Emphasizing regulatory compliance, Tonix underscores the necessity of clinical trials in expanding treatment offerings. Specific precautions for TONMYA entail monitoring for drug interactions, particularly serotonergic drugs, due to serotonin syndrome risk, and advising caution during pregnancy and lactation.