FDA Advances Acute Suicidal Ideation and Behavior Treatment

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 cannot be linked to signs of neurotoxicity at any studied doses. Research recently published in the American Journal of Psychiatry found that the effect of NRX-101 can also be evaluated using Magnetic Resonance Spectroscopy.

The Mass General Clinical Trials Network and Institute will lead the upcoming clinical trial, and Andrew Nierenberg, MD, will serve as the principal investigator of the study.