Tonix Pharmaceuticals Holding has completed the clinical portion of a human study of a solution version of TNX-102 2.4mg sublingual tablets (TNX-102 SL).
The comparative pharmacokinetic and bioavailability study, conducted in Canada by a clinical research organisation, evaluated a solution formulation of TNX-102 SL tablet containing 2.4mg of cyclobenzaprine.
TNX-102 is a control sublingual solution designed to simulate crushed immediate-release cyclobenzaprine tablets (2.4mg), oral ingestion of an immediate-release cyclobenzaprine tablet (5mg), and intravenous cyclobenzaprine (2.4mg).
TONIX chairman and president Seth Lederman said the company designed TNX-102 SL to work overnight following bedtime administration, with the goal of improving the pain and other symptoms of fibromyalgia syndrome by improving sleep quality.
"We view these results as highly encouraging. This was a stringent test of sublingual absorption of cyclobenzaprine, as patients receiving sublingual formulations were instructed to spit and rinse 90 seconds following administration," Lederman added.
"We believe the kinetics of plasma cyclobenzaprine demonstrated by TNX-102 SL will translate to more rapid effects compared with current cyclobenzaprine products."
The PK results demonstrated that the solution formulation of TNX-102 SL delivered cyclobenzaprine to the systemic circulation more efficiently than the sublingual solution of a simulated crushed tablet and faster than the ingested tablet.
In the study, which enrolled 23 healthy adult volunteers and periodically measured circulating blood levels of cyclobenzaprine over six days after receiving study medication, TNX-102 SL was well-tolerated, and no serious adverse events were reported.
The company expects to commence a pivotal clinical trial of TNX-102 SL tablets for fibromyalgia syndrome in the first quarter of 2013.