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FDA accepts IND for NRX-101 for suicide in bipolar depression

NeuroRx recently announced the FDA accepted an Investigational New Drug application for NRX-101, an oral fixed-dose combination of D-Cycloserine and lurasidone, for acute suicidal ideation and behavior in bipolar depression.

As a result, NeuroRx plans to conduct a phase 2b/3 study of NRX-101 and is currently enrolling study sites, according to a press release.

Findings from two phase 2 clinical trials indicated a 50% reduction in depression symptoms and 75% reduction in suicidal ideation among individuals with bipolar disorder who received D-cycloserine.

The FDA recently released a warning about neurotoxicity associated with prolonged or repeated use of ketamine, particularly among individuals aged younger than 3 years and pregnant women. However, a preclinical trial of NRX-101 indicated no detectable neurotoxicity at any studied dosages and met the requirement of at least a 10-fold safety margin of the maximum human dose.