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 bioavailability of the product is not impacted by food.
“We are pleased to report positive results for ET-101, which brings the product one step closer to the market. ET-101 represents a very large market opportunity and is an important part of our growing pediatric neurology portfolio,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We believe our proprietary oral liquid formulation will address a critical unmet need for pediatric epilepsy patients and we look forward to bringing the product to them as quickly as possible.”
Eton anticipates submitting a New Drug Application for ET-101 in the third quarter of 2020, which would allow for Food and Drug Administration (FDA) 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.