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November 22, 2011

FDA grants clearance for Tonix to begin TNX-102 study

Tonix Pharmaceuticals has received US Food Drug and Administration (FDA) approval to initiate a comparative pharmacokinetic and bioavailability study of TNX-102, an oral formulation of cyclobenzaprine for the treatment of fibromyalgia.

Tonix Pharmaceuticals has received US Food Drug and Administration (FDA) approval to initiate a comparative pharmacokinetic and bioavailability study of TNX-102, an oral formulation of cyclobenzaprine for the treatment of fibromyalgia.

TNX-102 is a gelcap containing very low dose cyclobenzaprine, designed for faster and improved absorption relative to conventional cyclobenzaprine products.

About 30 healthy adult volunteers will be enrolled in the single-dose, open-label, randomised and three-way crossover study, which will compare a TNX-102 candidate gelcap containing 2.4mg of cyclobenzaprine to a 5mg cyclobenzaprine tablet.

Additionally, the study will assess the effect of food on the pharmacokinetic profile of TNX-102 in subjects who are either fasting or fed with a high-fat, high-calorie breakfast.

Tonix chairman and president Seth Lederman said that if the study validates the company’s hypothesis, it would proceed with the first of two pivotal clinical trials.

"Our goal is to develop a bedtime cyclobenzaprine treatment with more predictable beneficial effects and possibly reduced next day drowsiness," Lederman said.

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