(RTTNews) - NRx Pharmaceuticals (NRXP) announced FDA has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. 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.
The company noted that the determination of unmet medical need aligns with the eligibility requirements for the Commissioner's National Priority Voucher Program 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.
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.
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