Tonix Pharmaceuticals Publishes Pharmacokinetic Study Supporting TONMYA's Mechanism for Fibromyalgia Treatment
Tonix Pharmaceuticals' peer-reviewed study demonstrates TONMYA's superior pharmacokinetic profile compared to oral cyclobenzaprine, supporting its use as the first new fibromyalgia treatment in over 15 years.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) 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(R), 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(TM) (cyclobenzaprine HCl sublingual tablets 2.8mg) represents the first new treatment for fibromyalgia in more than 15 years, addressing a significant unmet medical need in central nervous system disorders.
The publication's importance extends beyond fibromyalgia treatment validation. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder, potentially expanding the drug's therapeutic applications. The company's broader CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease.
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system and immunology treatments in areas of high unmet medical need. The company's CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace(R) SymTouch(R) and Tosymra(R). Additional information about the company is available in their newsroom at https://ibn.fm/TNXP.
Beyond CNS treatments, Tonix is 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's important to note that 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.
The pharmacokinetic study publication represents a significant milestone in validating TONMYA's mechanism of action and supporting its clinical use profile. For investors and the medical community seeking the latest updates, the company maintains its newsroom at https://ibn.fm/TNXP where additional information about TNXP developments is regularly posted.