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NRx Re-files FDA Application for Safer Ketamine Amid Drug Shortage

NRx Pharmaceuticals re-files FDA application for preservative-free ketamine KETAFREE™ amid drug shortage. Safer alternative targets $750M US market, eliminates neurotoxic preservative.

This development matters because ketamine has emerged as a crucial treatment for severe depression and other mental health conditions, particularly for patients who haven't responded to traditional antidepressants. The current drug shortage creates significant barriers to care for vulnerable populations. NRx's preservative-free formulation addresses safety concerns associated with benzethonium chloride, which has been linked to neurotoxicity. If approved, KETAFREE™ could provide a safer alternative during a critical period when access to ketamine treatments is limited, potentially improving outcomes for patients suffering from treatment-resistant depression, PTSD, and chronic pain while setting new safety standards in the rapidly expanding ketamine market.