NRx Pharmaceuticals Receives FDA Fast Track Designation for NRX-100 in Treating Suicidal Ideation in Depression Patients

Monday, Aug 11, 2025 8:06 am ET1min read

NRx Pharmaceuticals has been granted FDA Fast Track designation for NRX-100 to treat suicidal ideation in patients with depression, including bipolar depression. This designation expands the addressable population to 13 million Americans, a 10x increase from the original designation in 2017. FDA has determined that NRX-100 has the potential to address an unmet need, aligning with the Commissioner's National Priority Voucher Program and the FDA's Accelerated Approval Program.

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