NRx Pharmaceuticals, Inc. announced an expanded access policy for NRX-100, its preservative-free ketamine formulation. This policy allows physicians to request NRX-100 for patients suffering from serious or life-threatening suicidal depression who have not responded to currently available therapies.
This initiative follows the recent Fast Track designation granted by the U.S. Food and Drug Administration (FDA) for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression. The designation acknowledges the urgent unmet medical need addressed by NRX-100.
The expanded access program aims to provide a pathway for patients in critical need to receive this treatment while the company continues its regulatory process towards full FDA approval. Approximately 13 million adults seriously consider suicide each year, highlighting the importance of such access.
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