FDA grants NeuroRx drug NRX-101 breakthrough therapy certification

recently, NeuroRx(http://announced that itsdrug(http://NRX-101 has been certified by the U.SFDA(http://NRX-101 is primarily used to treat patients with severe bipolar depression with acute suicidal thoughts and behaviour (ASIB), and is the first oral quick-acting antidepressant to be awarded a breakthrough therapy certificationNeuroRx published its encouraging findings in a recent report in the STABIL-B study, which showed that NRX-101 was well tolerated with no serious adverse events and disruptive side effectsNRX-101
NRX-101 is an oral drug combination consisting of a fixed dose of D-cyclic serine (DCS), NMDA antagonist, lurasidone, with 5-HT2a receptor antagonist activityDCS increases levels of two neurotransmitters, glutamate and glutamine (Glx), compared to all previously approved antidepressantstherefore, NRX-101 may represent a new class of antidepressants that has the potential to truly reduce suicidal thoughts in patients with severe bipolar disorderClinical data obtained from the Multicenter STABIL-B feasibility study to assess the clinical effects of NRX-101 compared to the lurasidone control groupNeuroRx is currently conducting a key 2b/3 clinicaltrial(http://at SPA to treat patients with severe bipolar depression and acute suicidal thoughtafters after the initial stabilization of ketamine by comparing daily oral NRX-101 therapy with standard treatment (lurasidone)previously, NeuroRx was awarded fast TRACK certification by the FDA in August 2017