Aucta Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application

Aucta Pharmaceuticals announced that the Company has entered into an agreement with Eton Pharmaceuticals, Inc. to License U.S. marketing rights for AUC025.

AUC025 is an innovative patent-pending formulation of lamotrigine that will be delivered to patients as an oral liquid form. Aucta submitted the product’s New Drug Application (NDA) to the FDA in early 2019 and is seeking approval as an epilepsy treatment to be used 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. Lamotrigine is currently only approved in tablet forms, and Aucta believes AUC025 will fulfill a significant unmet need for pediatric patients requiring precision dosing.

Lamotrigine is one of the most widely used anti-epilepsy drugs with sales exceeding $700 million with more than 15 million prescriptions in U.S. annually. Initiation of epilepsy treatment with lamotrigine requires multi-week titration based on patient weight, and pediatric patients often require doses that are a fraction of the currently available tablet strengths. The dosing flexibility and patient friendly nature of the oral liquid form makes AUC025 a great addition to treat epilepsy.

“We are excited to be partnering with Eton. We look forward to working closely with Eton’s dedicated commercial team to bring this innovative treatment forward and to address the unmet medical need in epilepsy,” said Shoufeng Li, Chief Executive Officer of Aucta Pharmaceuticals.

“Eton is excited to add AUC025 to our growing pipeline of near-term product launches and further strengthen our neurology franchise. There remains a significant unmet medical need for precision dosing for pediatric patients, and we believe that AUC025 has the potential to fill the need,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. “Eton looks forward to working with Aucta to bring this important product to market as we gear up for its potential launch in the first half of next year.”