NRx Pharmaceuticals (NRXP) Secures FDA Expanded Access for Depression Drug NRX-101

NRx Pharmaceuticals (NRXP) announced June 22, 2026, that the U.S. Food and Drug Administration (FDA) granted an Expanded Access Protocol (EAP) for its lead investigational drug, NRX-101. This protocol allows patients with Suicidal Treatment-Resistant Bipolar Depression (STRBD) who have failed standard therapies to access the drug. The EAP provides a pathway for individuals with a high unmet medical need to receive NRX-101, a fixed-dose combination of D-cycloserine and lurasidone. NRX-101 previously received FDA Breakthrough Therapy Designation for STRBD, highlighting its potential to address a critical patient population. This expanded access is distinct from the ongoing Phase 2b/3 clinical trials for NRX-101. The EAP could broaden the drug's availability and generate additional real-world data ahead of potential market approval, offering an earlier treatment option for patients.