Tonix Pharmaceuticals has announced positive data from an animal pharmacokinetic (PK) study of its novel sublingual (SL) formulation of TNX-102, the company's very low dose cyclobenzaprine.
The preclinical data demonstrated that the company's SL TNX-102 2.4mg tablet provides faster delivery and more efficient absorption of cyclobenzaprine compared to the currently availiable pills that deliver cyclobenzaprine to the stomach.
Tonix chief executive officer Seth Lederman said the company is developing TNX-102 as a therapy to help people afflicted with fibromyalgia (FM) to get the relief they need, by improving sleep quality.
"The clinical data supports the idea that improving sleep quality leads to significant alleviation of FM symptoms," Lederman added.
"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."
The company identified 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 FDA and are marketed by other companies.
The company received Health Canada clearance to begin a pharmacokinetic / bioavailability study of an oral solution formulation of its SL TNX-102 tablet in comparison to a marketed oral cyclobenzaprine tablet (5mg) and to intravenous cyclobenzaprine (2.4mg) in healthy adults in Canada.
Tonix also plans to investigate the utility of low dose formulations of cyclobenzaprine in a new treatment paradigm for post-traumatic stress disorder.