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NRx Pharma's Ketamine Therapy Gets FDA Fast Track for Suicidal Depression

NRx Pharmaceuticals receives FDA Fast Track for NRX-100 ketamine therapy targeting suicidal depression. Expanded access now available for eligible patients with limited treatment options.

This development matters because suicidal depression represents a critical public health crisis with limited effective treatment options. Each year, thousands of people die by suicide, and current antidepressant therapies often take weeks to show effect, leaving vulnerable patients at continued risk. The FDA Fast Track designation accelerates the development and review process for promising treatments that address serious conditions with unmet medical needs. If proven effective, NRX-100 could provide immediate relief for suicidal ideation, potentially saving lives and offering hope to patients and families affected by severe depression. The expanded access policy also demonstrates a patient-centric approach, allowing those with no other options to potentially benefit from this investigational therapy while clinical trials continue.