USFDAJun 22, 2026, 07:01 AM
NRX Pharmaceuticals gets FDA approval for Expanded Access to NRX-101
AI Summary
NRX Pharmaceuticals announced FDA approval of an Intermediate Population Expanded Access Protocol for NRX-101. This allows patients with Treatment-Resistant Depression to access the investigational drug, a fixed-dose combination of D-cycloserine (DCS) and lurasidone, for augmenting accelerated Transcranial Magnetic Stimulation (TMS) while pivotal clinical trials are underway. The company aims to ensure this potentially life-saving drug is available, initially charging only for shipping and data collection costs. NRX-101 was developed to provide a stable, GMP-manufactured version of DCS, which has shown promise in enhancing TMS effectiveness.
Key Highlights
- FDA approved Intermediate Population Expanded Access Protocol for NRX-101.
- NRX-101 is a fixed-dose combination of D-cycloserine (DCS) and lurasidone.
- It is for augmentation of accelerated TMS in Treatment-Resistant Depression.
- Pivotal SPARC-TMS clinical trial is ongoing in civilian and military facilities.
- Company will initially charge only for shipping and FDA-required data collection.
- DCS has neuroplastic effects and may enhance TMS effectiveness.
- NRX-101 development required two years for stability and impurity control.
Price Impact
More from NRXP