NRx Pharmaceuticals announced that the FDA Office of Generic Drugs has determined that it has not identified any bioequivalence deficiencies in the company’s preservative-free ketamine product. The determination is deemed preliminary until final supervisory review, with anticipated FDA approval in Summer 2026.
The proposed NRx product is the first ketamine formulation to be free of benzethonium chloride (BZT), a known toxic preservative that is not listed by the FDA as Generally Recognized as Safe (GRAS). Benzethonium chloride is no longer permitted in certain topical consumer applications. Prior to NRx’s preservative-free formulation, it was widely believed that BZT was required to maintain room temperature stability and sterility of ketamine.
The company anticipates demonstrating three years of room temperature stability and sterility for its preservative-free product. NRx has filed patents in the US and internationally to support its preservative-free formulation and has the potential to create a “branded generic” product. The preservative-free product is manufactured in the United States at a time when the FDA has identified ketamine as a strategically important medication.
Regulatory and Manufacturing Context
The FDA recently awarded a Commissioner’s National Priority Voucher to support the establishment of a new U.S. manufacturing source of ketamine drug substance, reflecting broader regulatory and policy focus on re-shoring essential medicines and reducing reliance on foreign supply.
According to Dr. Jonathan C. Javitt, MD, MPH, NRx’s CEO and Chairman, “We believe a preservative-free formulation has the potential to meaningfully modernize ketamine therapy while supporting the resilience of the U.S. drug supply chain.”
Related Development
In addition to the pending ANDA application for preservative-free ketamine, NRx is preparing a New Drug Application under Fast Track Designation to expand the use of intravenous ketamine to treat patients with severe depression who may have suicidal ideation. NRX-100 has been awarded Fast Track Designation for this treatment, while NRX-101 (oral D-cycloserine/lurasidone) has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110871812/Nrx-Pharmaceuticals-NasdaqNRXP-Announces-FDA-Bioequivalence-Determination-By-Office-Of-Generic-Drugs-For-Nrxs-Preservative-Free-Ketamine-Application