NRx Pharmaceuticals, Inc. announced that the U.S. 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 represents a tenfold expansion of the addressable population for NRX-100 compared to its previous 2017 designation.
The FDA's determination of unmet medical need aligns NRX-100 with eligibility requirements for the Commissioner's National Priority Voucher Program (CNPV) and the FDA's Accelerated Approval Program, potentially expediting its review and approval process. Clinical trials submitted to the FDA demonstrated a statistically significant reduction of suicidal ideation.
In a Columbia University study licensed by NRx, suicidal patients treated with intravenous ketamine showed a 55% response rate compared to 30% for an active comparator. A French government-sponsored trial, also licensed by NRx, reported 63% of patients achieving full remission from suicidal ideation in three days compared to 31% for placebo.
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