NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) has completed an FDA Type C meeting for the NRX-100 New Drug Application (NDA) pathway. NRx is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD.
The company is developing two primary drug candidates: NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral formulation combining D-cycloserine and lurasidone. NRX-100 has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.
NRx has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. The completion of the Type C meeting represents a step forward in the regulatory process for bringing these neuropsychiatric treatments to patients.
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