NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company today announced further alignment with the FDA Division of Anesthesiology, Addiction Medicine, and Pain Medicine in connection with the development of NRX-101 for treatment of Chronic Pain. The communication took the form of a “Study May Proceed” letter, authorizing NRx to proceed with opening a pharmacokinetic study under the newly-established Investigational New Drug file for treatment of Chronic Pain. This is a formal letter that generally follows clearance of an IND and outlines nonclinical and clinical requirements suggested by the review division.
The preclinical requirements identified by FDA for this new indication are consistent with the already-implemented preclinical requirements previously identified by the Division of Psychiatry Products for the use of NRX-101 to treat Bipolar Depression, although the duration of some nonclinical studies will be extended for the anticipated longer treatment duration associated with Chronic Pain.
FDA advised NRx to focus on a specific type of pain in its initial registrational trials, which is consistent with NRx’s plan to attempt to replicate the clinically-significant benefit previously identified in association with treatment of low back pain, which is also the subject of the recently completed DOD-funded trial. With this alignment in place and with the current inventory of manufactured NRX-101 on hand for clinical trial use, the Company now awaits results from the already-completed DOD-funded trial of D-cycloserine vs. placebo (www.clinicaltrials.gov NCT03535688) in order to confirm the previously-identified efficacy signal and dosing range.
“We at NRx appreciate the rapid and supportive response from the FDA division that regulates pain products. The identified nonclinical requirements should not pose a significant financial burden or time delay in initiating a registrational trial of NRX-101 for treatment of Chronic Pain, should the already-completed 200 person clinical trial yield encouraging data,” said Stephen Willard, CEO of NRx Pharmaceuticals.