NRx Pharmaceuticals, Inc. announced the electronic filing of its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation. This ANDA seeks approval for use in all existing approved indications, including anesthesia and pain management.
The current annual ketamine market is estimated at $750 million, with global demand projected to grow to $3.35 billion by 2034. NRx aims to capture a significant share of this market, especially given a severe drug shortage reported by the American Society of Hospital Pharmacists, for which NRx is seeking priority review.
The company plans to file a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic preservative, from ketamine products. NRx has demonstrated that its preservative-free formulation maintains stability and sterility for single-patient use, aligning with regulatory priorities to remove toxic preservatives.
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