Eton Pharmaceuticals Reports Positive Study Results for ET-101 (Topiramate Oral Solution)
Eton Pharmaceuticals, Inc. (ETON)
Last eton pharmaceuticals, inc. earnings: 3/5 04:02 pm
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Source: GlobeNewswire
-Results Demonstrated Bioequivalence to the Currently Approved Oral Solid Formulation -Market for Topiramate in Oral Form is Greater than $800 million Annually DEER PARK, Ill., March 17, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced positive bioequivalence study results for ET-101, its proprietary oral solution formulation of topiramate. A bioequivalence study was conducted in healthy male subjects under fasting conditions, of Eton’s ET-101 oral solution compared to the existing FDA-approved topiramate oral solid product. The 90% confidence intervals for all pharmacokinetic (PK) parameters were within the 80 to 125% BE criteria demonstrating that ET-101 is bioequivalent to the comparator product under fasting condition. Further, a food effect study was conducted on ET-101 under fed conditions, which demonstrated that the bio
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