Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing non-addictive treatments for chronic pain syndromes, including fibromyalgia (“FM”), today reported positive data from an animal pharmacokinetic (“PK”) study of its novel sublingual (“SL”) formulation of TNX-102, the Company’s very low dose cyclobenzaprine.
“TONIX is developing TNX-102 as a therapy to help people afflicted with FM get the relief they need, by improving sleep quality,” said Seth Lederman, M.D., Chief Executive Officer of TONIX. “With better sleep quality, patients report a reduction in their chronic pain. Sleep quantity and sleep quality are different. The clinical data support the idea that improving sleep quality leads to significant alleviation of FM symptoms. We believe that improving sleep quality allows the natural restorative properties of sleep to work on reducing pain. TONIX is pursuing this goal through our novel formulations of cyclobenzaprine.”
FM is a common and complex central nervous system condition characterized by chronic diffuse musculoskeletal pain, increased pain sensitivity at multiple tender points, fatigue, abnormal pain processing, and disturbed sleep, and often features psychological stress. Despite the fact that most FM patients suffer from poor sleep, there are no medications indicated for FM that work by improving sleep. Research has shown that the restorative sleep of FM patients is disrupted by alarm signals called CAP A2 and A3. In a Phase 2a trial, TONIX demonstrated that bedtime administration of very low dose cyclobenzaprine improves core FM symptoms including pain, tenderness, fatigue, and depression, and also demonstrated that improvements in key symptoms correlate with increased nights of restorative sleep. These results were published in the December 2011 issue of the Journal of Rheumatology.
The new research reported by TONIX today demonstrates that the Company’s SL TNX-102 (2.4 mg) tablet provides faster delivery and more efficient absorption of cyclobenzaprine as compared to the currently available pills that deliver cyclobenzaprine to the stomach. In fact, TONIX discovered that cyclobenzaprine given in a novel SL formulation is absorbed as well as intravenous cyclobenzaprine. Cyclobenzaprine is the active ingredient in two prescription muscle relaxants that have been approved by the U.S. Food and Drug Administration and are marketed by other companies.