The U.S. Food and Drug Administration issued a letter on December 2 2025 confirming that NRx Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for KETAFREE™—a preservative‑free intravenous ketamine formulation—has reached substantial completion. The FDA’s letter sets a goal review date of July 29 2026, marking a key regulatory milestone that brings the company closer to commercial launch.
KETAFREE™ is a generic, preservative‑free version of ketamine that can be used for all currently approved indications. By eliminating benzethonium chloride, a preservative that the FDA has flagged as potentially unsafe, the product addresses a growing safety concern among clinicians and patients. The generic ketamine market is estimated at $750 million annually in the United States, with projections of $3.35 billion worldwide by 2034. A U.S.‑manufactured, preservative‑free product could capture a significant share of this expanding market while also mitigating the looming ketamine shortage that has affected hospitals and outpatient clinics.
NRx’s dual‑focused strategy—developing both drug products and a network of interventional psychiatry clinics through its HOPE Therapeutics subsidiary—provides a balanced revenue mix. The company’s recent financials show a net loss of $5.5 million for Q1 2025, an improvement from $6.5 million in Q1 2024, driven by a 52 % reduction in R&D expenses and an 11 % cut in G&A costs. These cost‑control measures position NRx to invest in the commercialization of KETAFREE™ while maintaining the operational efficiency needed to support its clinic network.
Jonathan Javitt, MD, MPH, Chairman and CEO of NRx, said, “We appreciate the FDA’s careful review and are pleased that it has received our application for KETAFREE™. This milestone brings us closer to delivering a single‑patient, preservative‑free ketamine presentation to the patients and clinicians who depend on this medicine.” His comments underscore the company’s confidence that the regulatory approval will translate into a safer, more accessible product for a large patient population.
The FDA’s ANDA prioritization program, which rewards U.S. manufacturing and R&D, further supports NRx’s reshoring initiative. By producing KETAFREE™ domestically, the company aligns with national efforts to strengthen the critical‑medicine supply chain and may benefit from expedited review pathways. The substantial‑completion determination, combined with the company’s cost‑control achievements and dual‑business model, positions NRx to capture a meaningful share of the growing ketamine market while reinforcing its commitment to patient safety and operational resilience.
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