NRx Pharmaceuticals gets FDA feedback on ketamine program

NRx Pharmaceuticals (NRXP) announced the receipt of a discipline review letter from the FDA Office of Generic Drugs and the completion of a meeting with leadership. The discipline review letter entitled “Quality” covers the areas of drug substance, drug product, manufacturing and microbiology. The letter requests only administrative changes and updates to prior stability data, all of which are identified as “minor.” This review letter follows the previously announced bioequivalence determination from the FDA Office of Generic Drugs on March 17 and represents a separate review discipline within the ANDA process. NRx additionally conducted a meeting with leadership of the FDA Office of Generic Drugs in which the national priority around expediting approval of ketamine, now documented in the President’s April 16 executive order, was recognized by FDA leadership. The executive order calls for expedited approval of drugs to treat severe depression and suicidality. The company said the approval of the preservative-free ketamine ANDA is particularly important because of supply shortages documented by physicians who seek to obtain ketamine for use in the clinic setting. FDA leadership expressed support for addressing the remaining aspects of the current ANDA application within the current review cycle that targets approval in Summer 2026.