NRx Pharmaceuticals Reports Q3 Progress with Key Regulatory Advancements for Depression Treatments

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) has reported third-quarter 2025 results highlighting substantial progress across its clinical pipeline for central nervous system disorders, with particular emphasis on advancing treatments for suicidal depression. The company noted its first revenue-generating activities alongside key regulatory milestones for both NRX-100 and NRX-101 programs.

For NRX-100, the company's preservative-free intravenous ketamine treatment, NRx has achieved expanded Fast Track status and maintains an active Expanded Access program for suicidal depression. The New Drug Application submission is supported by large-scale real-world ketamine data, providing substantial evidence for regulatory consideration. The company's Abbreviated New Drug Application pathway for its preservative-free ketamine formulation, branded as KETAFREE, remains on track for a Q2 2026 Generic Drug User Fee Act date. Recent FDA communication regarding the revised ANDA filing indicated no major deficiencies, signaling potential regulatory clearance ahead.

NRx continues its efforts to remove benzethonium chloride from commercial ketamine formulations, addressing safety concerns associated with current preservative-containing products. The company's regulatory strategy includes application for the Commissioner's National Priority Voucher Program for NRX-100 in suicidal depression treatment, which could provide significant development incentives.

For NRX-101, the company's oral D-cycloserine/lurasidone combination therapy, NRx has initiated its NDA submission process with Breakthrough Therapy Designation and rolling review status. This regulatory pathway allows for accelerated review and potential earlier patient access. The submission is supported by compelling real-world evidence demonstrating that D-cycloserine more than doubles the antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation therapy.

A confirmatory phase 3 clinical trial for NRX-101 is scheduled for early 2026, which will provide additional validation of the treatment's efficacy and safety profile. The company continues to expand its HOPE delivery platform with additional facilities planned in Florida, enhancing treatment accessibility for patients suffering from severe depression conditions.

The progress in these regulatory programs represents significant advancement in treating suicidal depression, a condition with limited effective therapeutic options. The combination of Fast Track Designation for NRX-100 and Breakthrough Therapy Designation for NRX-101 positions both treatments for potentially expedited regulatory pathways, which could translate to earlier patient access to these novel therapies. The company's focus on removing potentially harmful preservatives from ketamine formulations addresses important safety considerations in current treatment protocols.

For additional information about NRx Pharmaceuticals' corporate developments and clinical programs, visit https://www.nrxpharma.com. The latest updates and news regarding the company's progress are available through its corporate communications channels.