RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has achieved a significant milestone in the development of its antidepressant drug, NRX-100 (Ketamine). On September 24, 2024, the company announced that the first manufactured lot of NRX-100, produced at Nephron Pharmaceuticals, demonstrated twelve-month real-time stability without any degradation of the active ingredient. This stability suggests NRX-100 could have a shelf life exceeding three years at room temperature.
This milestone is crucial as stability testing is a fundamental requirement for the drug approval process by the U.S. Food and Drug Administration (FDA). With stability established, NRx is on course to file a New Drug Application (NDA) for NRX-100 later this year. Notably, NRX-100 is the first sterile, single-dose vial formulated without preservatives, which can pose toxic risks with repeated use.
“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,” stated Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. He also expressed gratitude to the team at Nephron Pharmaceuticals for their role in this achievement, highlighting the progress made in offering hope to those in need.
The successful stability results not only bring NRx Pharmaceuticals closer to FDA approval but also mark a significant step in potentially providing a new treatment option for individuals at risk of suicide, highlighting the company’s efforts to address mental health challenges.
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