NeuroRx is developing NRX-101, a oral, fixed dose combination of D-cycloserine and lurasidone, which has been awarded Breakthrough Therapy Designation and Fast Track Designation for the treatment of suicidal bipolar depression. NRX-101 demonstrated statistically-significant improvement on standard depression scales (MADRS) in phase 2 studies and is now entering phase 3 in both the US and China under an FDA Special Protocol Agreement, led by investigators at Harvard/Mass General, Baylor, Columbia, UAB, and Shanghai Jiaotong Medical University. The study is expected to read out in 2020. More than 1 million people each year die of suicidal depression and the only currently approved treatment is electroshock therapy. NRX-101 acts by simultaneous, dual-target inhibition of the glycine site of the NMDA receptor and the 5-HT2A receptor. Unlike direct NMDA channel blockers, such as ketamine and phencyclidine, NRX-101 is not hallucinogenic, neurotoxic, or habituating.
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