The FDA granted fast track designation to NRX-100 (NRx Pharmaceuticals, Inc) a ketamine-based drug, as a standalone therapy for the treatment of suicidal ideation in individuals with depression, including bipolar depression.
“We thank FDA for its thoughtful review of our fast track designation request and believe this regulatory determination is a significant step forward in our goal to address the national crisis of suicide among soldiers, first responders, veterans, and civilians alike.” Jonathan Javitt, MD, MPH, chairman and CEO of NRx Pharmaceuticals, said in a news release.
NRX-100 in Suicidal Ideation
According to the CDC, nearly 13 million individuals seriously consider suicide annually, with around 1.5 million attempts, marking suicide as the leading cause of death that impacts individuals of all ages. Suicide rates in the United States increased by approximately 36% between 2000 and 2022. The number of individuals impacted by suicidal thoughts and actions is much higher, with an estimated 12.8 million adults seriously considering suicide, 3.7 million planning, and 1.5 million attempting suicide in 2022 alone. In 2023, there were 49,316 deaths from suicide, which amounts to roughly 1 death every 11 minutes. Further data from 2023 identified that suicide was among the top 8 leading causes of death for individuals ages 10 to 64 years and the second leading cause of death for individuals 10 to 34 years.
As the first preservative-free presentation of ketamine, NRX-100 is designed to treat suicidality in individuals with depression and bipolar depression, as most individuals who die by suicide have a mental health condition.
Bipolar depression is a severe form of depression among individuals with bipolar disorder, experiencing low mood or loss of interest in most activities. Symptoms of bipolar depression and depressive episodes include overwhelming sadness, low energy and fatigue, lack of motivation, feelings of hopelessness or worthlessness, and suicidal ideation.
NRX-100 Indications
The current fast track designation is a 10-fold expansion of the addressable population for NRX-100, compared with the 2017 designation that was granted for NRX-100 in combination with NRX-101, which is a fixed-dose combination of D-cycloserine (DCS) and lurasidone for the treatment of suicidal bipolar depression.
The designation was supported by several well-controlled trials that demonstrated clinically meaningful and statistically significant reduction of suicidal ideation with NRX-100 treatment. Data from a Columbia University study found that individuals that experienced suicidal ideations treated with intravenous ketamine demonstrated a 55% response compared with a 30% response to an active comparator. In another study from the Government of France, 63% of individuals achieved full remission from suicidal ideation in 3 days compared with 31% of individuals who received a placebo.
“Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine. This drug was also proven to be non-inferior to electroshock therapy in treating depression without the negative side effects of ECT,” Javitt said in the news release.
The findings suggest that NRX-100 is more effective than a placebo and an active comparator and at least as effective as electroshock therapy. Currently, ketamine is FDA-approved as an anesthetic and was recently approved for its indicated uses in surgical pain management. Although insurance typically does not cover its use for depression, the company noted that they hope an FDA approval for NRX-100 will make the drug accessible to all Americans.
