MIAMI, June 5, 2026
NRx Pharmaceuticals, Inc. announced that new real-world evidence presented at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting demonstrated favorable outcomes for intravenous (IV) ketamine compared with intranasal esketamine in patients with treatment-resistant depression. The peer-reviewed analysis, conducted by researchers from Osmind and Yale University, evaluated electronic health record data from more than 10,000 patients and provides additional support for the potential role of ketamine-based therapies in addressing severe depressive disorders.
Real-World Analysis Shows Higher Remission and Response Rates
The retrospective study analyzed de-identified medical records from 8,224 patients treated with IV ketamine and 1,830 patients treated with intranasal esketamine across approximately 800 community psychiatry clinics. After matching patients based on baseline characteristics, investigators evaluated outcomes in a cohort of 3,560 individuals. Results showed that 34% of IV ketamine-treated patients achieved remission compared with 26% of patients receiving intranasal esketamine. In addition, 63% of IV ketamine patients demonstrated a clinical response, compared with 58% of patients treated with esketamine. Statistical analysis indicated that IV ketamine recipients were significantly more likely to achieve both treatment response and remission.
Findings Support Growing Interest in Real-World Evidence
Researchers reported that both treatment groups experienced meaningful and sustained reductions in depressive symptoms as measured by the PHQ-9 depression scale. However, IV ketamine demonstrated superior outcomes across key effectiveness measures. Investigators noted that the primary limitation of the study was its non-randomized design, meaning that unmeasured confounding factors could have influenced results. Despite this limitation, the findings contribute to the growing body of real-world evidence being considered by regulators and policymakers as an important complement to traditional clinical trial data in mental health research.
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Favorable Safety Profile and Future Potential
NRx Pharmaceuticals stated that the results align with its strategic focus on developing NRX-100, a preservative-free intravenous ketamine formulation currently being advanced for severe neuropsychiatric conditions, including suicidal depression. The company noted that recent regulatory and policy initiatives have highlighted the value of real-world evidence in evaluating treatments for depression and suicidality. NRx believes the study reinforces the need for larger confirmatory investigations and supports ongoing discussions with the U.S. Food and Drug Administration regarding future development pathways. In addition to NRX-100, the company is advancing NRX-101, an investigational oral therapy for suicidal bipolar depression, as part of its broader pipeline targeting central nervous system disorders.
Source: NRx Pharmaceuticals press release
