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news.Tonix Pharmaceuticals has completed dosing and plasma analysis of a pharmacokinetic (PK) study of its TNX-102 sublingual tablet, a formulation of cyclobenzaprine (CBP) for bedtime use.
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The PK study assessed a single dose of one 2.4mg tablet or two tablets (4.8mg) of TNX-102 SL or the presently-marketed 5mg CBP tablet.
The data revealed that both sublingual doses of TNX-102 SL confirmed faster systemic absorption when compared to oral administration of the 5mg CBP tablet.
Tonix chief executive officer Seth Lederman said Tonix is developing TNX-102 SL to help people afflicted with FM obtain pain relief by improving sleep quality.
"We believe we have identified a greatly improved formulation to be studied as a bedtime therapy in pivotal trials for fibromyalgia," Lederman added.
The blood levels of CBP were higher at 20, 30, 45 and 60 minutes after the administering TNX-102 SL compared to administration of the 5mg CBP tablet.