NRX Pharmaceuticals Inc. has announced that its drug NRX-100, an IV ketamine treatment for suicidality in patients with depression, including bipolar depression, has received Fast Track Designation from the FDA. This designation indicates that NRX-100 has the potential to address an unmet medical need, based on preliminary data. The Fast Track Designation facilitates expedited review processes and enhances communication with the FDA, potentially leading to Priority Review and Rolling Review. NRX Pharmaceuticals plans to submit patient-level data demonstrating the drug's efficacy in reducing suicidal ideation and depression. The company is also seeking eligibility for the Commissioner's National Priority Voucher Program and the FDA's Accelerated Approval Program, which could further expedite the regulatory review of NRX-100.
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