Pharma Focus Asia

Aucta Pharmaceuticals Announces Licensing for Lamotrigine New Drug Application

Friday, June 28, 2019

Aucta Pharmaceuticals, Inc. is a product company with a unique technology platform dedicated to the development and commercialization of branded products in the specialty sector. The company announced today that it has signed an agreement with Eton Pharmaceuticals, Inc. to give AUT025 sales rights to the US market to Eton Pharmaceuticals.

AUC025 is an innovative, patent-pending form of lamotrigine that will be delivered to patients as an oral solution. Aucta submitted a new drug application (NDA) to the FDA in early 2019, which will be used as an epilepsy treatment for partial epileptic seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome epilepsy. A comprehensive treatment of adjuvant therapy. Currently, the approved dosage forms of lamotrigine are tablets. Aucta believes that AUC025 will fill the huge demand for precise drug delivery in pediatric patients.

Lamotrigine is one of the most widely used anti-epileptic drugs, with annual sales exceeding $700 million in the United States and over 15 million prescriptions. The use of lamotrigine for epilepsy requires multiple weeks of dose adjustment based on the patient's body weight, while pediatric patients typically require a fraction of the currently available tablet size. The oral liquid dosage form has flexible dose adjustment and good patient compliance, which makes AUC025 an important supplement for epilepsy treatment.

“We are excited to work with Eton. We look forward to working closely with Eton's dedicated sales team to drive this innovative treatment and address the unmet clinical needs of the epilepsy treatment,” said Shoufeng Li, CEO of Aucta Pharmaceuticals.

“Eton is pleased to incorporate AUC025 into our growing portfolio of recent product launches and further strengthen our operational authorization for the nervous system. For the huge demand for precise drug delivery in pediatric patients, we believe that AUC025 has Filling the gap in this potential," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Eton looks forward to working with Aucta to bring this important product to market and is expected to launch in the first half of next year.”

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