NRx Pharmaceuticals (NASDAQ:NRXP) submitted an investigational new drug (IND) application to the FDA for the use of NRX-101 to treat chronic pain.
The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a U.S. patent for the use of D-cycloserine in the treatment of pain.
Nonclinical and substantial clinical data are already on file with FDA for NRX-101, which has already been granted breakthrough therapy designation for the treatment of suicidal bipolar depression.
In a statement, Dr. Jonathan Javitt, founder, chairman and chief ccientist of NRx, said that based on the preliminary evidence of efficacy already demonstrated for the use of D-cycloserine in chronic pain, “we plan to seek fast track designation, priority review, and breakthrough therapy designation for the use of NRX-101 to treat chronic pain.”
He said the company has already completed the “critical manufacturing components required by FDA in connection with our bipolar depression program and have sufficient quantities of our investigational drug on hand to launch registrational studies in 2024, pending the results of the recently completed clinical trial funded by the U.S. Department of Defense.”
One in five American adults suffers from chronic pain, a condition for which there are few good solutions, once NSAIDs and Tylenol-like drugs have been exhausted. NRX-101 targets the NMDA receptor in the brain, which has been demonstrated in extensive nonclinical and early clinical studies to mediate the pain pathway.