NRx Pharmaceuticals (NASDAQ: NRXP) has announced that the FDA has granted NRC-100 Fast Track Designation as a standalone drug for the treatment of suicidal ideation in patients with depression, including bipolar depression.
The designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year, and includes an FDA determination that it has the potential to address an unmet need based on the data submitted.
In a statement, Dr. Jonathan Javitt, chairman and CEO of NRx, commented, “We thank FDA for its thoughtful review of our Fast Track Designation request, and believe this regulatory determination is a significant step forward in our goal to address the national crisis of suicide among soldiers, first responders, veterans, and civilians alike.”
Dr. Javitt added, “Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine. This drug was also proven to be non-inferior to electroshock therapy in treating depression without the negative side effects of ECT. We look forward to working closely with the FDA in our quest to Bring Hope to Life.”
