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

(RTTNews) - 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.