FDA grants NRx expanded Fast Track for NRX-100 (IV ketamine) in suicidal depression

NRx Pharmaceuticals (NRXP) — NRx Pharmaceuticals said the FDA granted an expanded Fast Track designation (received August 8) for NRX-100, its preservative-free IV ketamine, covering suicidal ideation in patients with depression including bipolar depression.

The company said the broader label roughly ten-times the addressable population versus its original 2017 designation, to about 13 million Americans, and argued the agency's unmet-need finding supports eligibility for the Commissioner's National Priority Voucher program as it pursues an NDA.

Source: ir.nrxpharma.com

For the rest of that week's sector news, read our week in review.