TONIX Pharmaceuticals Completes Pharmacokinetic Study On New Formulation Of TNX-102 For Fibromyalgia
Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”) completed a pharmacokinetic (PK) study of the first formulation of its lead drug, TNX-102, for the treatment of fibromyalgia syndrome (“FM”). The study results 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. This research was published in the December 2011 edition of the Journal of Rheumatology and can be viewed by accessing the following link: http://jrheum.org/content/early/2011/08/30/jrheum.110194.full.pdf+html.
TONIX is developing new formulations of cyclobenzaprine that are designed for bedtime use. The Company is investigating different technologies to improve the absorption of cyclobenzaprine. The technology applied 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.
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 clinical portion of this study was completed at the end of 2011 and analyses of the data were completed during the first quarter of 2012.
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