NRx Pharma’s Preservative-Free Ketamine Wins FDA Suitability Approval | NRXP | NewsOut

Biotech investors and CNS therapeutics followers, NRx Pharmaceuticals (NASDAQ: NRXP) just cleared a major regulatory hurdle—receiving FDA suitability petition approval for Keta-FREE, its proposed preservative-free ketamine formulation.

This is a potential game-changer in the psychiatric and chronic pain treatment space. Unlike current ketamine products that often contain benzothonium chloride—a compound flagged by some experts as toxic—Keta-FREE offers a cleaner, single-patient solution. With an estimated market opportunity of $750 million, the approval enables NRX to refile its abbreviated new drug application (ANDA).

The road ahead includes manufacturing, regulatory follow-through, and competing in the CNS space—but this win puts NRXP firmly in the spotlight.

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