- FDA grants NRx Pharmaceuticals approval of a Suitability Petition for single-patient preservative-free ketamine.
- The decision enables re-filing of an Abbreviated New Drug Application (“ANDA”) for the company’s KETAFREE(TM) product, which the company has now done.
- Current ketamine formulations use multidose vials with a toxic preservative, Benzethonium Chloride.
- U.S. ketamine market is estimated at $750 million annually, presenting a significant commercial opportunity.
- NRx is also advancing NRX-100 and NRX-101 for suicidal depression and PTSD, both with FDA designations.
- The move aligns with U.S. policy goals on reshoring drug production and reducing toxic additives.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Suitability Petition to advance KETAFREE(TM), a preservative-free version of ketamine (https://ibn.fm/qFzsh). 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 (https://ibn.fm/nogJi).
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…
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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