NRx Pharmaceuticals announced the 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.
In 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) and for the FDA's Accelerated Approval Program. The Company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100.
Several 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 active comparator (P<.02). In a trial sponsored by the Government of France and licensed by NRx, 63% of patients achieved full remission from suicidal ideation in three days compared to 31% of those who received placebo (P<.001). This effect has not been proven with intranasal administration of ketamine.
"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." said Dr. Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals. "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."
Under the terms of the Fast Track program, NRx will be posting an expanded access policy for NRX-100 in the next two weeks and seeking a meeting with FDA leadership to finalize the data to be submitted under the Accelerated Approval/CNPV application. In addition to the benefits above, Fast Track Designation also grants enhanced communication with the FDA, as well as potential Priority Review and Rolling Review.
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