NeuroRx Announces FDA IND Clearance for NRX-101 Phase 2B/3 Study and Publication of Promising Biomarker Data
January 04, 2017 at 10:07 am EST
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NeuroRx developing the first oral therapy for Acute Suicidal Ideation and Behavior in Bipolar Depression has received FDA clearance to proceed with its phase 2b/3 study protocol under an Investigational New Drug (IND) application and is now enrolling study sites for its clinical trial of NRX-101. The clinical trial, details of which are posted on www.clinicaltrials.gov, seeks to demonstrate that NRX-101 is safe and effective in maintaining remission from ASIB and depression following initial stabilization with ketamine. NRX-101 is a fixed dose combination of D-Cycloserine, a glycine site NMDA antagonist and lurasidone, a 5-HT2a antagonist. The Mass General Clinical Trials Network and Institute will provide leadership for the clinical trial, and Prof. Andrew Nierenberg, M.D., Director of Bipolar Research in the department of Psychiatry at Massachusetts General Hospital will serve as the study's Principal Investigator.
NRX Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is developing therapeutics based on its N-methyl-D-aspartate (NMDA) platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and post-traumatic stress disorder (PTSD). The Company has two lead compounds, NRX-100, a proprietary presentation of ketamine and NRX-101, a fixed-dose combination of D-cycloserine (DCS) and lurasidone. The Company is developing NRX-101, a Food and Drug Administration (FDA)-designated investigational therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRX-101 is a combined NMDA/5-HT2A-targeted medicine designed to address both depression and suicidal ideation, consisting of an oral, fixed dose combination of DCS and lurasidone. Its NRX-100 is racemic ketamine, which is a generic anesthetic. The Company is also engaged in the development of its new product, NRX-102.
NRX PHARMACEUTICALS, INC. 
