WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) said the U.S. Food and Drug Administration has authorized an Expanded Access Protocol for its investigational depression treatment NRX-101, potentially allowing certain patients with treatment-resistant depression to receive the therapy before completion of a pivotal clinical trial.
The FDA authorization permits use of NRX-101 in combination with accelerated Transcranial Magnetic Stimulation (TMS) under the agency’s expanded access framework, which is designed to provide investigational treatments to patients with serious or life-threatening conditions who are unable to participate in clinical trials.
NRX-101 combines D-cycloserine and lurasidone and is being studied as a treatment intended to enhance the effectiveness of TMS, a noninvasive brain stimulation therapy used to treat depression.
The company said it has launched a pivotal study known as SPARC-TMS, which will evaluate whether the drug-TMS combination can improve remission rates for depression and suicidality among patients with treatment-resistant depression. The trial is being conducted at civilian and military treatment facilities.
The expanded access program is intended for patients who cannot enroll in the ongoing study but may qualify for treatment under FDA-authorized compassionate-use mechanisms.
Interest in D-cycloserine as a potential TMS-enhancing therapy has grown following published research suggesting the drug may improve treatment outcomes by promoting neuroplasticity, the brain’s ability to form new neural connections.
NRx said the doses under investigation differ from those used in the currently approved tuberculosis formulation of D-cycloserine, leading some clinicians to rely on compounded versions of the drug. The company argued that compounded formulations are not subject to the same FDA manufacturing oversight, stability testing, and quality-control requirements as regulated pharmaceutical products.
Under the expanded access protocol, NRx plans to provide NRX-101 while charging only for shipping and FDA-required data collection costs, rather than the investigational drug itself, according to the company.
“We look forward to reporting the results of our upcoming pivotal trial, SPARC-TMS, 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,” said Dr. Joshua Brown, the company’s chief medical innovation officer.
The FDA authorization does not constitute approval of NRX-101. The treatment remains investigational and its safety and effectiveness have not yet been established through the ongoing pivotal trial.
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