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news.The US Food Drug and Administration (FDA) has issued approval to Tonix Pharmaceuticals to initiate a comparative pharmacokinetic (PK) and bioavailability (BA) study of TNX-102, an oral formulation of cyclobenzaprine for the treatment of Fibromyalgia (FM).
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TNX-102 is a bedtime gelcap with very low dose cyclobenzaprine, which aids in faster and improved absorption as compared to conventional cyclobenzaprine products.
The single-dose open-label randomised three-way-crossover PK/BA study will enroll about 30 healthy adult volunteers to compare a TNX-102 candidate gelcap containing 2.4 milligrams of cyclobenzaprine to a five milligram cyclobenzaprine tablet.
Additionally, the study will assess the effect of food on the PK of TNX-102 in subjects who are either fasting or fed with a high-fat, high-caloric breakfast.
The Phase 2a study has demonstrated the improved nights of restorative sleep with bedtime very low dose cyclobenzaprine.