FDA Grants NRx Expanded Access Protocol For NRX-101 In Treating Depression

(RTTNews) - NRx Pharmaceuticals Inc. (NRXP), a biopharmaceutical company, on Monday announced the granting of an Expanded Access Protocol from the U.S. Food and Drugs Administration to facilitate use of NRX-101, the compounded drug of D-cycloserine and Lurasidone, for transcranial magnetic stimulation in treating depression.

D-cycloserine (DCS) is commonly prescribed for the treatment of tuberculosis, but in smaller doses and in combination with other drugs, proves effective against treatment-resistant depression and suicidality. These conditions are often more vulnerable to treatment when neuroplasticity is promoted in the brain, as new synapses and connections are key aspects for the reversal of depression.

NRX-101, the DCS and lurasidone compounded drug, was previously awarded Breakthrough Therapy designation for the treatment of suicidal bipolar depression. The drug will be evaluated in the pivotal SPARC-TMS study to augment transcranial magnetic stimulation (TMS) for patients in remission, to be conducted across civilian and military facilities.

As compounded drugs do not require FDA approval, the real-world evidence provided by the study will inform further modifications to dosing and administration.

Under the Expanded Access Protocol, NRX-101 will be made available to physicians and patients requiring treatment for life-threatening mental illnesses.

NRXP is currently trading at $4.03, up 1.64%.