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The FDA accepts a New Drug Application for novel antidepressant.
The US Food and Drug Administration has reviewed and accepted the New Drug Application (NDA) for LY03005, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI). Developed under Luye Pharma's New Chemical and Therapeutic Entities Research and Development platform, the company has obtained patents covering the chemical compound, crystal form, and formulation of LY03005.1
Unlike other available antidepressants, it is believed the SNDRI class of medications will be relatively beneficial in preserving patients' sexual functions. Data also suggests SNDRIs will have a better safety profile, produce a more rapid onset, and provide better efficacy.1
SNDRIs fall under the category of triple reuptake inhibitors (TRIs), since they simultaneously target serotonin transporters, norepinephrine transporters, and dopamine transporters. TRIs are emerging as a promising class of antidepressants. It is believed that, compared with monoamine transporters, their broader spectrum inhibition would lead to enhanced efficacy and faster antidepressant response while also addressing a broader range of symptoms (including anhedonia).2
The company originally filed for the NDA in late December 2019 after consensus was reached with the FDA under End-Of-Phase 2-CMC meeting and Pre-NDA meeting.3 Luye Pharma has made a commitment to their central nervous system pipeline; they currently are working on compounds for the treatment of schizophrenia, bipolar disorder, and Alzheimer disease.
"The global patient population affected by depression and other CNS diseases is large and growing, with serious distress caused by these diseases greatly affecting both patients and their families. We look forward to bringing more high-quality and innovative drugs to the market, helping these patients in need", said a senior management representative from Luye Pharma Group.1
1. Luye Pharma Press Release. NDA Filing for Luye Pharma’s Antidepressant Drug LY03005 Accepted by the U.S. FDA. March 4, 2020.
2. Sharma H, Santra S, Dutta A. Triple reuptake inhibitors as potential next-generation antidepressants: a new hope?Future Med Chem. 2015;7:2385-2406.
3. Luye Pharma Press Release. Luye Pharma Submits New Drug Application in the U.S. for Its Antidepressant Drug LY03005. December 26, 2019.