---
title: "NRx Pharmaceuticals's NRX-101 Wins FDA Approval For Intermediate Population Expanded Access Protocol"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/290430893.md"
description: "NRx Pharmaceuticals announced FDA approval for an Expanded Access Protocol for NRX-101, a combination therapy for depression. The company will provide the drug to eligible patients during ongoing pivotal trials at no cost, covering only shipping and data collection fees. Additionally, the SPARC-TMS study was initiated to evaluate the treatment's efficacy in treating treatment-resistant depression. Following the news, NRXP stock rose 1.94% to $4.04 in pre-market trading."
datetime: "2026-06-22T11:52:25.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/290430893.md)
  - [en](https://longbridge.com/en/news/290430893.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/290430893.md)
generator: "portal-rs"
---

# NRx Pharmaceuticals's NRX-101 Wins FDA Approval For Intermediate Population Expanded Access Protocol

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NRx Pharmaceuticals, Inc. (NRXP), Monday announced that the Food and Drug Administration has approved an Intermediate Population Expanded Access Protocol for the use of NRX-101, a fixed dose combination of D-cycloserine and lurasidone for the augmentation of accelerated Transcranial Magnetic Stimulation for the treatment of depression.

Under the Expanded Access Protocol, the company has decided to provide NRX-101 to doctors and eligible patients while pivotal clinical trials continue with the goal to ensure that this potentially life-saving treatment is available as quickly as possible to patients who qualify for it.

The company also announced the initiation of the Synaptic Plasticity Augmented Rapid Circuit Stimulation or SPARC-TMS study, which aims to determine the efficacy of the NRX-101-TMS combination in achieving remission from depression and suicidality in patients with Treatment-Resistant Depression.

Initially, patients will only need to cover shipping expenses and the costs associated with FDA-required data collection. The company will not charge for the investigational drug itself.

In the pre-market hours, NRXP is trading at $4.04, up 1.94 percent on the Nasdaq. 

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**