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Aucta Pharmaceuticals filing for epilepsy drug accepted by US FDA

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Aucta Pharmaceuticals filing for epilepsy drug accepted by US FDA

Eton Pharmaceuticals Inc. said the U.S. Food and Drug Administration accepted Aucta Pharmaceuticals' application seeking approval of the medicine ET-105 as an add on therapy for seizures in epilepsy patients.

Deer Park, Ill.-based Eton had acquired U.S. marketing rights for ET-105 — an oral liquid formulation of anti-epileptic drug lamotrigine — from Aucta in June. Lamotrigine is an FDA-approved treatment but only in a tablet form, Eton said in an Aug. 1 press release.

Eton added that Aucta is seeking approval of ET-105 as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older.

Lennox-Gastaut syndrome is a severe form of epilepsy that mostly becomes apparent during infancy or early childhood. While partial seizure affects only one part of the brain, a generalized seizure occurs throughout the whole brain. Primary generalized tonic-clonic seizure cause symptoms in the entire body.

The FDA is expected to make a decision on the new drug application by March 17, 2020.

Eton CEO Sean Brynjelsen said the company plans to work with Aucta and the FDA over the coming months as it prepares for a potential commercial launch of the drug in the first half of 2020.