Eton Pharmaceuticals Reports Positive Study Results for ET-101 (Topiramate Oral Solution)
-Results Demonstrated Bioequivalence to the Currently Approved Oral Solid Formulation
-Market for Topiramate in Oral Form is Greater than
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
Eton anticipates submitting a New Drug Application for ET-101 in the third quarter of 2020, which would allow for
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
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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Source: Eton Pharmaceuticals