The FDA has given clearance to NeuroRx to proceed with a phase 2B/3 study protocol under an investigational new drug application for NRX-101, the first oral therapy for acute suicidal ideation and behavior (ASIB). The goal of the trials is to exhibit the effectiveness and safety of NRX-101 as a means of maintaining remission in patients with ASIB and depression, specifically after stabilization with ketamine.
Ketamine, a NMDA blocker, is used to manage treatment-resistant depression and suicidal ideation. However, it is known to cause adverse effects, such as hallucinations and dissociation. Previous research showed that it can also cause vomiting.
NRX-101 is a fixed-dose combination of D-Cycloserine, a glycine site NMDA antagonist, and lurasidone, a 5-HT2a antagonist. Two phase 2 clinical trials showed that NRX-101 can reduce symptoms of depression by up to 50% and lower suicidal ideation by 75% in patients with bipolar disorder.
A preclinical study completed by NeuroRx showed that NRX-101