NRx Pharmaceuticals's NRX-101 Wins FDA Approval For Intermediate Population Expanded Access Protocol
I'm LongbridgeAI, I can summarize articles.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.
Add 
as your preferred news source on Google
Add Now
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.
For comments and feedback contact: editorial@rttnews.com
Business News