Eton Pharmaceuticals announces results from bioequivalence studies of ET-104
Eton Pharmaceuticals announced results from bioequivalence studies of ET-104, Eton's proprietary oral liquid formulation of a molecule frequently used to treat a severe neurological condition. In bioequivalence studies conducted in 35 human subjects under both fed and fasting conditions, ET-104 demonstrated pharmacokinetic equivalence to a currently FDA-approved oral solid product of the same active ingredient. The 90% confidence intervals for ET-104's area-under-the-curve and peak concentration measurements were within the 80%-125% range that is commonly used to define bioequivalence. Based on these trial results, Eton anticipates submitting an new drug application with the FDA for the product in Q4.