NRx noted that filing of the new-drug application for NRX-100 “is on track for 2024.”
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NRx Pharmaceuticals said it has completed 12 months of real-time stability on the first manufactured lot of NRX-100 at Nephron Pharmaceuticals, utilizing commercial-scale processes.
NRx reached the milestone on Sept. 24, according to the company.
“In this process, no degradation of the active ingredient was observed,” the company noted in a press release. “These findings are consistent with projected room-temperature shelf stability in excess of three years. Accelerated stability on additional manufactured lots of preservative-free product is congruent with stability seen in this initial lot.”
NRx recently announced plans to submit a new-drug application for NRX-100 – IV ketamine – for the treatment of suicidal depression, “based on results of well-controlled clinical trials conducted under the auspices of the U.S. National Institutes of Health and newly obtained data from French health authorities, licensed under a data-sharing agreement.”
The U.S. Food & Drug Administration awarded the company fast-track designation for NRX-100 as part of a protocol to treat patients with acute suicidality.
The NRX-100 formulation is the first sterile, single-dose vial prepared without the addition of preservatives, according to the company.
“Demonstrating the ability to manufacture drug product, and prove its stability, are critical components of the drug-approval process with the U.S. FDA,” NRx asserted in a news release.
NRx noted that filing of the new-drug application for NRX-100 “is on track for 2024.”
“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, M.D., MPH, chairman and chief scientist of NRx Pharmaceuticals. “I would like to congratulate the manufacturing team from our partner Nephron Pharmaceuticals for helping us take this important step forward in bringing hope to life.”