Tonix Pharmaceuticals (OTCBB: TNXP) develops new treatments for challenging disorders of the central nervous system (CNS). The Company’s lead programs are potential new treatments for fibromyalgia and post-traumatic stress disorder, which are chronic CNS syndromes. In each of these programs, TONIX seeks to use new doses and formulations of cyclobenzaprine in new treatment regimens. Cyclobenzaprine is the active ingredient of two prescription muscle relaxants that have been approved by the U.S. Food and Drug Administration (FDA) and are marketed by other companies.
The Company has completed a pharmacokinetic (PK) study of the first formulation of its lead drug, TNX-102, for the treatment of fibromyalgia syndrome (“FM”). The results from the study “support further development of TNX-102 as a product that can potentially deliver benefits similar to those observed in FM patients treated with very low dose cyclobenzaprine in the Company’s dose-escalating Phase 2a study.” A publication of the Phase 2a study can be found at: http://jrheum.org/content/early/2011/08/30/jrheum.110194.full.pdf+html.
The Company is working to develop "new formulations of cyclobenzaprine that are designed for bedtime use" and is looking into different technologies to improve the absorption of cyclobenzaprine. The technology used in this study "involves a mixture of cyclobenzaprine and lipids that the Company obtained from Lipocine, Inc. and is designated TNX-102 2.4 mg promicellar gelatin capsules, or gelcaps."
According to the press release,
"The PK study was conducted on healthy subjects in Canada under a U.S. Investigational New Drug Application, or IND, and a Canadian Clinical Trial Application, or CTA. This cross-over randomized study assessed the blood levels of cyclobenzaprine in approximately 30 healthy adult volunteers after they ingested either a TNX-102 2.4 mg promicellar gelcap or a marketed, generic version of Flexeril® 5 mg immediate release cyclobenzaprine. Circulating blood levels of cyclobenzaprine after oral administration of the TNX-102 2.4 mg promicellar gelcap in a fed or fasting state were determined and compared to the blood levels resulting from oral administration of the currently marketed 5 mg immediate release tablet (“tablet”) in a fasting state."
The study's clinical portion was completed at the end of 2011. Analyses of the data were completed during the first quarter of 2012.