2020-03-17 08:11:15 ETON Eton Pharmaceuticals
03/17/20 03/1708:11 03/17/2008:11 | Eton Pharmaceuticals reports bioequivalence study results for ET-101Eton Pharmaceuticals announced 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 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 bioavailability of the product is not impacted by food. Eton anticipates submitting a New Drug Application for ET-101 in the third quarter of 2020, which would allow for Food and Drug Administration approval as early as the second quarter of 2021. ET-101 is expected to be the first oral solution of topiramate approved by the FDA. The current market for topiramate in oral form is greater than $800 million annually according to IQVIA data. Eton's product is specifically designed to offer patients precision dosing and an ease of administration that is not available from existing FDA-approved treatment options. Due to this current unmet need, topiramate is one of the most frequently compounded neurology oral liquids. ET-101 is the third product in Eton's pediatric neurology pipeline, along with ET-105, its lamotrigine for oral suspension product candidate, and ET-104. ET-101's unique proprietary formulation is stable at room temperature storage. Eton is seeking approval of ET-101 for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older, as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older, and for the preventive treatment of migraine in patients 12 years of age and older. |
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