Core Insights - NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine formulation, to the FDA for use in approved indications such as anesthesia and pain management [1][2] Industry Overview - The current annual ketamine market is estimated at $750 million, with projections indicating growth to $3.35 billion globally by 2034 [2][6] - An estimated 5.1 million Americans have received ketamine for medical uses, with demand continuing to rise due to increased clinical focus [2][6] - There is a severe drug shortage of ketamine in the U.S., which is not expected to improve in the near future [6] Company Developments - NRx Pharmaceuticals aims to capture a significant share of the existing ketamine market with its NRX-100 formulation, which eliminates the neurotoxic preservative benzethonium chloride [3][5] - The company plans to file a citizen's petition with the FDA to remove benzethonium chloride from all intravenous ketamine presentations [3][6] - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients to support the extension of ketamine's labeled indications to include treatment for suicidal depression [4][8] Regulatory and Patent Status - The FDA has granted a waiver of the $4.3 million NDA fee for NRX-100, recognizing its public health value [5] - NRX-100 has received Fast Track Designation from the FDA, and the company has filed a patent for this novel formulation, seeking protection until 2045 [5][8]