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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression
This designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year and represents a 10x expansion of
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"This designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year and represents a 10x expansion of the addressable population compared to the Designation granted in 2017 for bipolar depression aloneThe Designation includes an FDA determination that NRX-100 has the potential to address an unmet need, based on FDA's assessment of the data submittedDetermination of \"unmet need\" is a requirement for a Commissioner's National Priority Voucher (CNPV) program.Suicide is a public health crisis. Approximately 13 million adults seriously consider suicide each year, according to the CDC, 3.7 million make a plan to commit suicide. An American dies from suicide every 11 minutes. Active-duty personnel, veterans, and first responders have a four-fold higher risk of suicide.WILMINGTON, Del., Aug. 11, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a clinical-stage biopharmaceutical company, today announced US Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. This designation for NRX-100 as a standalone drug is a 10-fold expansion of the addressable population for NRX-100, compared to the designation granted in 2017 for NRX-100 in combination with NRX-101 (DCS/lurasidone) for treatment of Suicidal Bipolar Depression.\n\n \n \n \n \n \n \n\n \nIn granting the Fast Track designation, FDA made the determination that NRX-100 has the potential to address an unmet medical need, based on an assessment of the preliminary data contained in the Fast Track designation request. This determination of unmet medical need aligns with the eligibility requirements for the Commissioner's National Priority Voucher Program (CNPV)i and for the FDA's Accelerated Approval Program.ii The Company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100.\nSeveral well-controlled trials submitted to FDA in support of Fast Track Designation demonstrated a clinically meaningful and statistically significant reduction of suicidal ideation. In a Columbia University study licensed by NRx, suicidal patients treated with intravenous ketamine demonstrated a 55% response (i.e. 50% reduction in suicidality) compared to a 30% response to ac...