NRx Pharmaceuticals to File Two New Drug Applications for Depression Treatments NRX-101 and NRX-100

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NRx Pharmaceuticals announced intentions to file two New Drug Applications (NDAs) this year based on advice from regulatory experts, including former FDA officials. According to the company, these applications include an Accelerated Approval for NRX-101, a treatment for bipolar depression in patients with akathisia, and standard approval of NRX-100 (IV ketamine) for treating suicidal depression. Filing of the data is contingent upon the completion of a 12-month stability data as per FDA requirements.¹

"The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help," said Jonathan Javitt, MD, MPH, chairman, chief scientist, NRx, in a press release. "Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner."

NRX-101 is classified as an oral combination of the NMDA antagonist D-cycloserine and lurasidone for bipolar depression. According to data from two active control clinical trials, it has demonstrated antidepressant efficacy with clinically important reductions in suicidality and/or akathisia comparable to lurasidone, which is the current standard of care. Previously, NRX-101 was granted Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA.

NRx describes IV ketamine as a standard of care for the acute treatment of suicidal depression. Data from the same clinical trials mentioned above resulted in NRx filing the NDA for NRX-100 to treat patients with suicidal depression.

Reportedly, around 15% of patients treated with drugs similar to lurasidone have developed akathisia, which currently has no FDA-approved cure. Additionally, the Center for Disease Control and Prevention (CDC) estimates that close to 3.5 million people in the United States make a suicide plan annually.¹

According to the Cleveland Clinic, an estimated 10% to 18% of people who have bipolar I disorder and take antidepressants will develop akathisia. Antidepressants associated with akathisia include selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, and tricyclic (TCA) antidepressants. Additionally, medications that treat vomiting, high blood pressure, sedatives, calcium channel blockers, and vertigo can lead to akathisia.²

“Akathisia is the most common movement disorder associated with psychotropic medication, particularly antipsychotic (neuroleptic) medications, reports the Mayo Clinic.” “Approximately 24% of people who have schizophrenia and are taking medication for it have chronic akathisia.”

Between 2000 and 2018, suicide rates in the United States increased by 37%. In 2021, it was the 11th leading cause of death in the country. It is more common in males, with the most common group being middle-aged white men. In Native American and Alaskan Native populations, it is a leading cause of death among all age groups. Further, approximately 82% of transgender people have considered suicide.³

“Depression and suicide are linked, with an estimate that up to 60% of people who die by suicide have major depression, reports Very Well Mind. “However, it's important to note that this figure doesn't mean most people with depression will attempt suicide. “Research suggests that the majority of suicides are related to a psychiatric condition, including depression, substance use disorders, and psychosis. Estimates indicate that the suicide risk for mental illnesses, including depression, alcoholism, and schizophrenia is around 5% to 8%”

References

1. NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing. PR Newswire. June 28, 2024. Accessed July 1, 2024. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-to-proceed-with-two-new-drug-applications-in-2024-nrx-101-has-been-returned-to-the-company-for-filing-302185390.html

2. Akathisia. Cleveland Clinic. Accessed July 1, 2024. https://my.clevelandclinic.org/health/diseases/23954-akathisia

3. Suicide Statistics in the United States. Verywell Mind. October 10, 2023. Accessed July 1, 2024. https://www.verywellmind.com/suicide-rates-overstated-in-people-with-depression-2330503