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.
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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.
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"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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