NetworkNewsBreaks – NRx Pharmaceuticals Inc. (NA
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NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, recently secured approval from the U.S. Food and Drug Administration (“FDA”) for its Suitability Petition to advance KETAFREE(TM), a preservative-free version of ketamine. “The ruling allows the company to re-file its Abbreviated New Drug Application (‘ANDA’) for the product, which it has now done, a key step in bringing it to market,” reads a recent article. “Currently, ketamine is sold in multidose vials that require preservatives to maintain sterility after repeated use. The most common additive, Benzethonium Chloride, is known to be toxic. NRx’s proposed alternative eliminates preservatives by using single-patient dosing, a change the company argues improves safety and aligns with updated public health priorities… Beyond KETAFREE(TM), NRx continues to build out a pipeline of therapies focused on central nervous system disorders. Its preservative-free intravenous formulation NRX-100 has received Fast Track Designation for the treatment of suicidal depression, including bipolar depression. A related program, NRX-101, has earned Breakthrough Therapy Designation for suicidal bipolar depression. These programs complement the KETAFREE(TM) initiative, underscoring the company’s emphasis on addressing urgent psychiatric needs.”
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