Therapy Areas: Central Nervous System
US FDA receives Luye Pharma's new drug application for LY03005
27 December 2019 -

The United States Food and Drug Administration (FDA) has received a new drug application (NDA) from Luye Pharma Group, an international pharmaceutical company, for its LY03005, a new chemical drug intended for the treatment of major depressive disorder, it was reported yesterday.

The product is also the second US FDA NDA involving the central nervous system (CNS) that the company has filed.

The application was based on the arrangement reached with the FDA under End-Of-Phase 2-CMC (EOP2-CMC) meeting and Pre-NDA (PNDA) meeting. LY03005 is an exclusive CNS product developed under the company's new chemical/therapeutic entities R&D platform. It is a serotonin-norepinephrine-dopamine triple reuptake inhibitor, and one of the active metabolites is a serotonin-norepinephrine reuptake inhibitor.

Luye Pharma has obtained patents covering the chemical compound, crystal form and formulation of LY03005.