NRx Pharmaceuticals Announces Further Alignment with FDA on Initiation of Registrational Trials for NRX-101 in the Treatment of Chronic Pain
"Study May Proceed" letter received from FDA
IND preclinical requirements are consistent with studies already in progress to support treatment of Bipolar Depression
Potential to initiate registrational studies in 2024, pending receipt of data from already-completed DOD-funded trial of D-cycloserine
RADNOR, Pa., Oct. 26, 2023 /PRNewswire/ -- 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.
About NRx Pharmaceutical
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company's lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor and is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression (S-TRBD), which includes patients with both acute and sub-acute suicidality, an indication for which the only approved treatment is electroshock therapy. The Company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of S-TRBD, to help bring NRX-101 to a global population of patients with unmet medical need. NRx Pharmaceuticals is currently exploring NRX-101's potential to act as a non-opioid chronic pain treatment option and has recently announced a renewed focus on the use of intravenous ketamine for treatment of acute suicidality.
Cautionary Note Regarding Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management. Actual results could differ materially from those contemplated by the forward-looking statements. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, as may be supplemented, or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by these cautionary statements.
The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
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