Tonix Pharmaceuticals Publishes Pharmacokinetic Study Supporting TONMYA’s Mechanism for Fibromyalgia Treatment

Tonix Pharmaceuticals Holding Corp. announced the publication of a peer-reviewed study detailing the steady-state pharmacokinetic properties of TNX-102 SL, the sublingual formulation of cyclobenzaprine HCl marketed as TONMYA, in Clinical Pharmacology in Drug Development. The study, conducted in 60 healthy volunteers, demonstrated that the sublingual formulation achieves faster absorption, earlier peak plasma concentration and higher dose-normalized bioavailability compared to oral extended-release cyclobenzaprine.

These pharmacokinetic findings support TONMYA’s use for long-term bedtime dosing to target nonrestorative sleep in fibromyalgia, reduce pain and improve related symptoms. TONMYA represents the first new treatment for fibromyalgia in more than 15 years, addressing a significant unmet medical need in central nervous system disorders. The full study details are available through the journal publication, and additional information about Tonix Pharmaceuticals can be found in the company’s newsroom at https://ibn.fm/TNXP.

The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra. Beyond fibromyalgia, Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. The company’s broader 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. It is important to note that the company’s product development candidates are investigational new drugs or biologics whose efficacy and safety have not been established and have not been approved for any indication beyond TONMYA’s approved use for fibromyalgia.

The publication of this pharmacokinetic data in a peer-reviewed journal provides scientific validation for TONMYA’s delivery mechanism and supports its differentiated profile compared to traditional oral formulations. For investors and stakeholders following the company’s progress, additional updates relating to TNXP are available through the company’s communications channels. The full press release containing this announcement can be accessed at https://ibn.fm/AX1hL.

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