{"id":609298,"date":"2026-08-20T07:33:29","date_gmt":"2026-08-20T07:33:29","guid":{"rendered":"https:\/\/www.olympiajournal.com\/news\/story\/609298\/fda-first-cycle-review-of-preservativefree-ketamine-anda-with-no-drug-related-major-deficiencies-noted-for-suicidal-bipolar-depression-treatment-from-nrx-pharmaceuticals-inc-nasdaq-nrxp.html"},"modified":"2026-08-20T07:33:29","modified_gmt":"2026-08-20T07:33:29","slug":"fda-first-cycle-review-of-preservativefree-ketamine-anda-with-no-drug-related-major-deficiencies-noted-for-suicidal-bipolar-depression-treatment-from-nrx-pharmaceuticals-inc-nasdaq-nrxp","status":"publish","type":"post","link":"https:\/\/www.olympiajournal.com\/news\/story\/609298\/fda-first-cycle-review-of-preservativefree-ketamine-anda-with-no-drug-related-major-deficiencies-noted-for-suicidal-bipolar-depression-treatment-from-nrx-pharmaceuticals-inc-nasdaq-nrxp.html","title":{"rendered":"FDA First Cycle Review of Preservative-Free Ketamine ANDA with No Drug Related Major Deficiencies Noted for Suicidal Bipolar Depression Treatment from NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)"},"content":{"rendered":"
\"FDA<\/a><\/div>\n
<\/div>\n
$NRXP Has Also Treated its First Patients Using Zeta Surgical’s FDA-Cleared Zeta TMS Navigation System<\/div>\n

WILMINGTON, DELAWARE – Aug. 20, 2026 –<\/strong> NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) 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. NRXP<\/strong> is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.<\/p>\n

NRXP <\/strong>is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP<\/strong> was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.<\/p>\n

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Second Quarter 2026 Financial Results and Corporate Update<\/strong><\/p>\n

NRXP<\/strong> announced financial results for the quarter ended June 30, 2026, and provided a corporate update. The quarter was marked by significant progress on multiple fronts and strengthening of the NRXP<\/strong> balance sheet to provide adequate funds for at least one year of operations and commercial launch.<\/p>\n

Highlights included:<\/p>\n

Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer’s attestation on the vial, has been submitted to FDA.<\/p>\n

Initiation of commercial scale manufacturing of preservative-free ketamine building to launch stock of 5 million doses to be ready for commercialization in 2026.<\/p>\n

NRXP<\/strong> selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS, an FDA-approved Phase 2\/3 trial of NRX-101 with robotic TMS. Anticipated non-dilutive funding exceeds $11.5 million, subject to completion of contracting.<\/p>\n

Advancing NRXP<\/strong> NRX-100 NDA on Real World Evidence from more than 65,000 patients, leveraging a Presidential Executive Order and Congressional budget language that encourage FDA use of such evidence in approving treatments for depression.<\/p>\n

Closed an institutionally-supported, underwritten public offering of common stock for gross proceeds of $22.3 million, including full exercise of the underwriters’ option. NRXP<\/strong> expects existing cash to fund operations for at least one year.<\/p>\n

NRXP<\/strong> HOPE Therapeutics expanded its clinical footprint with new sites in Sarasota and Boca Raton, Florida, and became the first commercial site in the US to treat patients using Zeta Surgical’s FDA-cleared TMS navigation system.<\/p>\n

Glenn Tyson appointed as the first NRXP<\/strong> Chief Commercial Officer and commercial launch team retained for preservative-free ketamine.<\/p>\n

For the six months ended June 30, 2026, NRXP<\/strong> reported a net loss of $18.0 million, versus a net loss of $23.1 million during the comparable period in 2025. As of June 30, 2026, NRXP<\/strong> had approximately $26.7 million in cash and cash equivalents versus $7.8 million as of December 31, 2025. The increase was primarily related to completion of a public offering of common stock with gross proceeds of more than $22 million. NRXP<\/strong> management believes current cash resources, anticipated growth in clinic revenue, and opportunistic utilization of active at-the-market offering facility will be sufficient to support operations for at least one year.<\/p>\n

FDA Completes First-Cycle Review of Preservative-Free Ketamine ANDA with No Drug Related Major Deficiencies<\/strong><\/p>\n

NRXP<\/strong> announced that the FDA has completed first-cycle review of the Company’s ANDA for its preservative-free ketamine, with no major deficiencies related to the drug product, ingredients, proposed labeling, Chemistry, Manufacturing and Controls, or other drug-related review matters. No new clinical, safety, efficacy, or drug-related data are required for ANDA approval. Following receipt of the FDA comments, NRXP<\/strong> held a clarification meeting with FDA on August 6, 2026 to confirm the remaining information required to support approval. The meeting was attended by leadership of the FDA Center for Drug Evaluation and Research (CDER) and the Office of Generic Drugs.<\/p>\n

FDA identified a remaining question related to evidence that the luer lock tip of the NRXP<\/strong> medication vial would perform properly when connected to a syringe by a licensed health professional. Because the question related to the product’s container closure system, it was classified by FDA as a Major Deficiency. Importantly, this remaining item is packaging-related and does not relate to the ketamine drug product itself, its ingredients, proposed labeling, CMC, or other drug-related review matters.<\/p>\n

Current industry statistics suggest only 14% to 18% of ANDA products are approved during first cycle review. NRXP<\/strong> believes that completion of this first review cycle with no drug-related major deficiencies and only a packaging-related certification remaining represents a meaningful regulatory milestone and substantially de-risks the path to commercialization.<\/p>\n

Prompt review of the remaining certification would be consistent with ongoing public health efforts to address the current ketamine shortage, strengthen U.S.-based supply of strategic medicines, and support the objectives of the April 20, 2026 Presidential Executive Order aimed at advancing breakthrough mental health treatments for veterans and other patients in need.<\/p>\n

Currently, NRXP<\/strong> believes the vast majority of ketamine for sale in the United States is manufactured outside the U.S. at a time when demand for ketamine continues to increase. Additionally, all other forms of IV ketamine contain a preservative that is no longer permitted by FDA in new drugs, hand cleansers or topical antiseptics.<\/p>\n

NRx Defense Systems, Inc., Subsidiary Selected by Defense Advanced Research Projects Agency (DARPA) for Contract Negotiations on Clinical Trial Award <\/strong><\/p>\n

NRXP<\/strong> filed a form 8-K announcing that its newly formed research and development subsidiary, NRx Defense Systems, Inc., was selected by the Defense Advanced Research Projects Agency (DARPA) Defense Sciences Office (DSO) for contract negotiations regarding a potential clinical trial award.<\/p>\n

NRXP<\/strong> received a letter from the Defense Advanced Research Projects Agency (“DARPA”), Defense Sciences Office (DSO), notifying the Company that its proposal to conduct a clinical trial, entitled Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) had been selected by DARPA for negotiation of a potential award.<\/p>\n

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The protocol for the SPARC-TMS trial was approved as a phase 2\/3 trial by the US Food and Drug Administration (FDA) and is posted on www.clinicaltrials.gov<\/a> (NCT07227103). The trial aims to demonstrate the potential efficacy of robotic-enabled Transcranial Magnetic Stimulation combined with NRXP<\/strong> NRX-101 (combined D-cycloserine\/lurasidone) in achieving remission from depression. NRX-101 which is patented by NRXP<\/strong> was previously awarded Breakthrough Therapy Designation by the FDA. The study is planned to be conducted at Harvard Mclean hospital, at clinics operated by HOPE Therapeutics, and at designated military treatment facilities including the Walter Reed National Military Medical Center.<\/p>\n

FDA Grant of Expanded Access Protocol for Use of D-Cycloserine-Based NRX-101 for Augmentation of Transcranial Magnetic Stimulation for Depression<\/strong><\/p>\n

NRXP<\/strong> announced the approval by FDA of an Intermediate Population Expanded Access Protocol for the use of NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone for the augmentation of accelerated Transcranial Magnetic Stimulation (TMS). Expanded Access Protocols are part of FDA’s compassionate care approach to making investigational drugs available to patients with serious or life-threatening medical conditions.<\/p>\n

FDA Completes First-Cycle Review of Preservative-Free Ketamine ANDA with No Drug Related Major Deficiencies.<\/em><\/p>\n

First Patients Treated Using Zeta Surgical’s Zeta TMS Navigation System. <\/em><\/p>\n

Subsidiary Selected by Defense Advanced Research Projects Agency (DARPA) for Contract Negotiations on Clinical Trial Award. <\/em><\/p>\n

FDA Grant of Expanded Access Protocol for Use of D-Cycloserine-Based NRX-101 for Augmentation of Transcranial Magnetic Stimulation for Depression. <\/em><\/p>\n

Clinical Leadership by Physicians Trained at Harvard, Johns Hopkins, Georgetown, and Other Leading Universities.<\/em><\/p>\n

Worldwide Generic Ketamine Market Estimated at $750 Million Per Year.<\/em><\/p>\n

About NRx Pharmaceuticals, Inc. (NASDAQ: NRXP)<\/strong><\/p>\n

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP)<\/strong> is a clinical-stage biopharmaceutical company focused on developing innovative treatments for serious central nervous system (CNS) disorders, with particular emphasis on suicidal depression, suicidal bipolar depression, PTSD and chronic pain. The company is developing therapies designed to address significant unmet medical needs, while also building HOPE Therapeutics, a clinical-care platform focused on advanced interventional psychiatric treatment.<\/p>\n

NRx’s mission is “to bring hope” through life-saving medicines for people living with unmet medical needs. The company says it seeks to use breakthrough science to make diseases that are difficult or previously untreatable more manageable, with a particular focus on bringing innovative treatments to patients with serious and life-threatening conditions.<\/p>\n

NRx Pharmaceuticals, Inc. was legally incorporated in Delaware on September 18, 2017<\/p>\n

For more information on $NRXP visit: https:\/\/www.nrxpharma.com\/<\/a> and https:\/\/compasslivemedia.com\/case-study\/nrx-pharmaceuticals\/<\/a><\/p>\n

Email:<\/strong> brian.korb@astrpartners.com<\/p>\n

DISCLAIMER: https:\/\/corporateads.com\/disclaimer\/<\/a><\/p>\n

Disclosure listed on the CorporateAds website<\/em><\/p>\n

Media Contact<\/span>
Company Name:<\/strong> NRx Pharmaceuticals, Inc.
Contact Person:<\/strong> Matthew Duffy, Chief Business Officer
Email:<\/strong> Send Email<\/a>
Phone:<\/strong> 484 254 6134
Address:<\/strong>1201 Orange Street Suite 600
City:<\/strong> Miami
State:<\/strong> Florida
Country:<\/strong> United States
Website:<\/strong> https:\/\/www.nrxpharma.com\/<\/a><\/p>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

$NRXP Has Also Treated its First Patients Using Zeta Surgical’s FDA-Cleared Zeta TMS Navigation System WILMINGTON, DELAWARE – Aug. 20, 2026 – NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/posts\/609298"}],"collection":[{"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/comments?post=609298"}],"version-history":[{"count":0,"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/posts\/609298\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/media?parent=609298"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/categories?post=609298"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.olympiajournal.com\/news\/wp-json\/wp\/v2\/tags?post=609298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}