NRx Pharmaceuticals, a Wilmington, Delaware-based commercial biopharmaceutical company developing treatments for depression, PTSD, and suicidality, has begun selling its newly approved preservative-free ketamine, the company announced on November 11, 2026. A 17-person sales force started work this week, with supply agreements and preorders targeted for late 2026. Shipments are scheduled to begin in January 2027.
“By enlisting seasoned sales representatives who already sell sterile injectable drugs, we are able to drive considerable efficiency in costs of sales and marketing,” said Jonathan Javitt, MD, MPH, Chief Executive Officer of NRx. “Our representatives already have strong relationships with hospital and group purchasing responsible for the vast majority of ketamine and other sterile injectable drugs sold in the U.S.”
According to NRx, its sales team has relationships with buyers responsible for about 80% of current U.S. ketamine sales.
A Needle-Free Vial
NRx’s ketamine comes in a blow-fill-seal (BFS) vial, a plastic container formed, filled, and sealed in a single manufacturing step. The vial has a luer-lock tip that attaches directly to a sterile syringe, so staff don’t need a needle to draw the drug. The product is regulated by the U.S. Food and Drug Administration (FDA) as a drug/device combination.
NRx says the design improves safety and saves time for pharmacy and hospital staff. It cites Centers for Disease Control and Prevention (CDC) estimates that hospital healthcare workers suffer about 385,000 needlestick and sharps injuries a year. The vial also produces no sharps waste.
The company says BFS manufacturing can also cut production costs well below those of traditional glass vials.
The Preservative Question
According to NRx, all ketamine injection products currently on the U.S. market contain the preservative benzethonium chloride (BZT). The FDA has not determined that BZT is “generally recognized as safe and effective” (GRASE) for use in over-the-counter antiseptic hand rubs.
NRx has filed a citizen petition asking the FDA to remove BZT from ketamine. A toxicology report on the FDA docket, prepared for the petition, argues that patients receiving typical hospital doses of ketamine may be exposed to BZT above the FDA’s published maximum daily intravenous exposure of 1 milligram.
Shortage and U.S. Manufacturing
Ketamine has been on the FDA’s drug shortage list since 2018, according to NRx. When FDA-approved ketamine isn’t available, hospitals may turn to compounding pharmacies. Most states limit compounded sterile products to a 90-day beyond-use date, while NRx’s product has an initial two-year expiration date.
NRx manufactures its ketamine in South Carolina. The company has contracted with German BFS equipment suppliers to double its manufacturing footprint there, with plans to add more U.S.-made sterile injectable products.
About NRx Pharmaceuticals
NRx develops treatments based on its NMDA receptor platform for central nervous system disorders, including suicidal depression, chronic pain, and PTSD. Beyond its preservative-free ketamine approval, the company is seeking approval for NRX-100, an intravenous ketamine presentation, for depression and suicidality. NRX-100 has FDA Fast Track Designation for suicidal ideation in depression, including bipolar depression. Its oral drug NRX-101 (D-cycloserine/lurasidone) has Breakthrough Therapy Designation for suicidal bipolar depression. In October 2026, the Defense Advanced Research Projects Agency (DARPA) awarded NRx an $11.25 million contract for a Phase 3 trial of NRX-101 combined with robotic transcranial magnetic stimulation as a one-day depression treatment.
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Source: NRx Pharmaceuticals, https://ir.nrxpharma.com/news-releases/news-release-details/nrx-pharmaceuticals-begins-selling-us-made-preservative-free on November 11, 2026. Republished with credit to the original author. Read the original article.
