NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced the achievement of twelve-month real-time stability for its NRX-100 (Ketamine) formulation, a significant step towards its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the treatment of suicidal depression. The milestone, reached on September 24, 2024, confirms that the first manufactured lot of NRX-100 at Nephron Pharmaceuticals, utilizing commercial-scale processes, showed no degradation of the active ingredient over the testing period.
This stability data indicates that NRX-100 has a projected room temperature shelf stability exceeding three years. Further accelerated stability testing on additional manufactured lots of the preservative-free product aligns with the initial findings. This is particularly important as demonstrating manufacturing stability is a critical component of the FDA's drug approval process.
The NRX-100 formulation is the first sterile, single-dose vial of ketamine prepared without preservatives, potentially avoiding toxic side effects associated with preservatives used in current multi-dose preparations. Ketamine is currently used off-label for suicidal ideation, but FDA approval is typically required for insurance reimbursement.
Management Commentary
"We are pleased to reach this important milestone in our preparation of the NDA for NRX-100, a drug we believe can significantly benefit the 3.8 million people who make a plan to commit suicide in the United States each year," said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. He also acknowledged the contribution of Nephron Pharmaceuticals in achieving this milestone.
About NRX-100 and NRx Pharmaceuticals' Pipeline
NRx Pharmaceuticals is focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. In addition to NRX-100, the company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company plans to file an NDA for Accelerated Approval for NRX-101 in inpatients with bipolar depression and suicidality or akathisia. NRX-101 also has potential as a non-opioid treatment for chronic pain and complicated UTI.
NRx Pharmaceuticals was granted Fast Track Designation by the FDA for the development of ketamine (NRX-100) as part of a protocol to treat patients with acute suicidality. The planned NDA submission for NRX-100 is based on data from clinical trials conducted under the auspices of the US National Institutes of Health and data from French health authorities, licensed under a data sharing agreement.
