The FDA has assigned the application a PDUFA target action date of March 17, 2020.
Sean Brynjelsen, MBA
The FDA has accepted the new drug application for ET-105, an innovative formulation of lamotrigine, as an adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 2 years of age and older.
ET-105, a patent-pending formulation of lamotrigine, will be delivered to patients as an oral liquid. The therapy has been developed specifically to address the unmet need in those with dysphagia and pediatric patients requiring precision dosing at levels below the currently available tablet strengths.
“The NDA acceptance of ET-105 marks an important milestone for Eton as this strengthens our growing pipeline of near-launch products. We are very excited about the potential for ET-105 to address a significant unmet need in this large and growing market,” Sean Brynjelsen, chief executive officer of Eton Pharmaceuticals, said in a statement.1 “Our team looks forward to working with Aucta and the FDA over the coming months as we prepare for a potential commercial launch in the first half of 2020.”
The application has a prescription drug user fee act target action date of March 17, 2020.
In June 2019, Eton Pharmaceuticals acquired the US marketing rights to Aucta Pharmaceuticals’ ET-105 therapy.
Currently lamotrigine (Lamictal) is indicated as an adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients ≥2 years of age; as a monotherapy in patients ≥16 years of age with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single antiepileptic drug; and as a maintenance treatment for bipolar I disorder to delay the time to occurrence of mood episodes in patients ≥18 years of age treated for acute mood episodes with standard therapy.
Lamotrigine tablets are available in doses of 25 mg, 100 mg, 150 mg, and 200 mg, chewable dispersible tablets of 2 mg, 5 mg, and 25 mg, and orally disintegrating tablets of 25 mg, 50 mg, 100 mg, and 200 mg.
The most common adverse events in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash. In children, adverse events included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor.2
1. Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105 [news release]. Deer Park, Ill.; Eton Pharmaceuticals. August 1, 2019. http://www.globenewswire.com/news-release/2019/08/01/1895523/0/en/Eton-Pharmaceuticals-Announces-FDA-Acceptance-of-New-Drug-Application-for-ET-105.html. Accessed August 1, 2019.
2. Lamictal [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2009. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf. Accessed Aug. 1, 2019.