NRx Pharmaceuticals Begins Commercial Sales of Preservative-Free Ketamine
Wilmington-based NRx Pharmaceuticals has begun selling its newly approved preservative-free ketamine, the company announced on Wednesday.
- NRx Pharmaceuticals deployed a 17-person sales force in November 2026 to distribute a new preservative-free ketamine product manufactured in South Carolina.
- The product uses a needle-free blow-fill-seal vial with a luer-lock tip, designed to eliminate sharps waste and reduce needlestick injuries.
- Ketamine has remained on the FDA drug shortage list since 2018, pushing hospitals to rely on compounding pharmacies with shorter 90-day beyond-use dates.
Sales Force Begins Work Ahead of 2027 Shipments
As BioBuzz noted, a sales team consisting of 17 people commenced operations this week, aiming for preorders and supply agreements by 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. According to NRx, its sales team holds existing relationships with buyers responsible for about 80% of current U.S. ketamine sales.
Blow-Fill-Seal Vials Allow Drawing Drugs Without Needles
The newly approved ketamine arrives in a blow-fill-seal vial, a plastic container formed, filled, and sealed in a single manufacturing step. The vial features a luer-lock tip that attaches directly to a sterile syringe, allowing hospital staff to draw the drug without a needle.
The product is regulated by the U.S. Food and Drug Administration as a drug/device combination. NRx cited Centers for Disease Control and Prevention estimates indicating that hospital healthcare workers suffer about 385,000 needlestick and sharps injuries each year, a risk this design aims to mitigate while producing no sharps waste.
NRx Petitions FDA to Remove Benzethonium Chloride Preservative
All ketamine injection products currently on the U.S. market contain the preservative benzethonium chloride, according to NRx. The FDA has not determined that benzethonium chloride is generally recognized as safe and effective for use in over-the-counter antiseptic hand rubs.
NRx filed a citizen petition asking the FDA to remove the preservative from ketamine. A toxicology report prepared for the petition argues that patients receiving typical hospital doses of ketamine may be exposed to the chemical above the FDA’s published maximum daily intravenous exposure of 1 milligram.
Ketamine has stayed on the FDA drug shortage list since 2018. While most states limit compounded sterile products to a 90-day beyond-use date, the NRx product carries an initial two-year expiration date.
NRx Expands South Carolina Manufacturing and Develops New Treatments
NRx manufactures its ketamine in South Carolina. To expand its local production capacity twofold, the firm partnered with German providers of blow-fill-seal machinery, intending to incorporate additional sterile injectables made in the United States.
Beyond its preservative-free ketamine approval, NRx develops treatments based on its NMDA receptor platform for central nervous system disorders. The company is seeking approval for NRX-100, an intravenous ketamine presentation, for depression and suicidality. NRX-100 holds FDA Fast Track Designation for suicidal ideation in depression, including bipolar depression.
Its oral drug NRX-101 has Breakthrough Therapy Designation for suicidal bipolar depression. NRx secured an $11.25 million award from the Defense Advanced Research Projects Agency in October 2026 to fund a Phase 3 evaluation of NRX-101 paired with robotic transcranial magnetic stimulation as a rapid, single-day therapy for depression.
Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.