NRx Pharmaceuticals Wins FDA Expanded Access Approval for NRX-101 TMS Augmentation
NRXP•On June 22, 2026, FDA approved an Intermediate Population Expanded Access Protocol for NRx Pharmaceuticals’ NRX-101, a fixed-dose D-cycloserine/lurasidone combination to augment accelerated Transcranial Magnetic Stimulation in treatment-resistant depression. The protocol enables physicians to provide NRX-101 under compassionate use, charging only for shipping and data collection.
1. FDA Grants Expanded Access Protocol
On June 22, 2026, the FDA authorized an Intermediate Population Expanded Access Protocol for NRX-101, enabling its use in combination with accelerated Transcranial Magnetic Stimulation (TMS) for patients with treatment-resistant depression. This designation allows regulated, GMP-manufactured D-cycloserine/lurasidone to be supplied under compassionate use to qualified patients.
2. Mechanism of NRX-101 Augmentation
NRX-101 combines D-cycloserine, a potent neuroplasticity agent, with lurasidone to enhance remission rates and reduce suicidality when paired with accelerated TMS. Preclinical and clinical studies have reported that D-cycloserine can potentiate synaptic connectivity changes induced by TMS, targeting depressive circuits more effectively.
3. Compassionate Use Implementation and Next Steps
Physicians may register to access NRX-101 through the company’s online portal, initially covering only shipping and FDA-required data collection costs. Meanwhile, NRx Pharmaceuticals is conducting the SPARC-TMS pivotal trial in civilian and military treatment centers to formally assess remission outcomes with the NRX-101–TMS regimen.
