Naurex Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of GLYX-13, the company's rapid-acting antidepressant in Phase 2 clinical development, as adjunctive therapy in major depressive disorder. GLYX-13 has shown rapid-acting antidepressant activity with excellent safety in a single-dose Phase 2a clinical study in subjects who had failed treatment with existing agents, producing statistically significant reductions in depression scores within 24 hours that lasted several days. Naurex expects to report results from a repeat-dose Phase 2b clinical study during the first half of this year.
GLYX-13 is Naurex's lead compound for the treatment of diseases of the central nervous system (CNS) based on the company's proprietary platform for discovering novel compounds that act at the NMDA receptor to modulate neuronal plasticity. Naurex's second-generation antidepressant, NRX-1074, is in Phase 1 clinical studies. Additional novel compounds generated from the Naurex platform are in preclinical development for a number of serious CNS disorders.
"GLYX-13 has the potential to address the urgent need for safe and effective antidepressant agents with a rapid onset of action, making it a strong candidate for the FDA's Fast Track program," said Dr.
Norbert Riedel, president and chief executive officer of Naurex. "We look forward to working closely with the FDA to advance the GLYX-13 clinical program and expedite its progress through the regulatory process." The FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review, and potential approval.
Fast Track designation may result in eligibility for priority review or accelerated approval of the candidate's New Drug Application.