NRx Prescription drugs introduced the grant of a submitting price waiver by the US Meals and Drug Administration (FDA) to exempt NRx from a $4.3 million price to file its New Drug Software for preservative-free ketamine (NRX-100). NRX-100 is a preservative-free formulation of intravenous ketamine for acute suicidal crises in despair.1
“We at NRx are inspired by this vital price waiver from the FDA and by the posture expressed by the brand new management of the Division of Well being and Human Providers in assist of recent psychedelic medicine to deal with the greater than 3 million People who take into account suicide yearly and presently haven’t any permitted remedy apart from electroshock remedy,” stated Dr. Jonathan Javitt, CEO and Chairman of NRx Prescription drugs. “NRx goals to make its preservative-free ketamine out there to physicians who look after sufferers with suicidal despair.”
NRx will submit knowledge from managed medical trials that show ketamine to be superior to each a placebo and an energetic comparator. Moreover, the corporate will search to show NRX-100 is superior to electroshock remedy in treating varied types of despair, together with in sufferers with energetic suicidal ideation.
NRX-100 gives a “preservative-free” formulation. At present out there types of ketamine comprise the preservative benzethonium chloride, however its security for repeated use has by no means been demonstrated. The truth is, the preservative was added again within the Nineteen Seventies when ketamine was initially formulated as an anesthetic, and though benzethonium chloride has not demonstrated toxicity in anesthesia, the category of preservatives has been proven to be neurotoxic and cytotoxic to eye tissue when included in eye drops.2 NRx-100 has now demonstrated stability and sterility for greater than 2 years of shelf life.
Additionally vital to notice is accessibility. Though ketamine is more and more getting used for treatment-resistant despair and associated problems,3 it is just FDA-approved to be used as an anesthetic and isn’t reimbursed by most insurance coverage carriers for remedy of main depressive dysfunction or suicidality. By making use of for FDA approval to deal with suicidal despair with NRX-100, NRX hopes to make this remedy out there to all People searching for remedy and never simply those that will pay out of pocket.
NRX-100 was initially granted Quick Monitor Designation by the FDA in 2017 to be used together with NRX-101 (D-cycloserine/lurasidone) for remedy of acute suicidality in bipolar despair.4 Right this moment’s waiver, granted on the discretion of the FDA to Small Enterprise Entities and for medicine which can be deemed to be vital for public well being, may allow the completion of NRX’s New Drug Software for NRX-100. The NDA submitting is anticipated by the tip of the second quarter of this yr.
References
1. NRx Prescription drugs, Inc. (NASDAQ:NRXP) Proclaims FDA Award of Submitting Price Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Software to Deal with Sufferers with Suicidal Melancholy. Information launch. FirstWord Pharma. Might 1, 2025. https://firstwordpharma.com/story/5955621
2. Goldstein MH, Silva FQ, Blender N, et al. Ocular benzalkonium chloride publicity: issues and options. Eye (Lond). 2022;36(2):361-368.
3. Bender Okay. Gradual-release oral ketamine formulations present promise for at-home remedy of resistant despair. Psychiatric Instances. September 4, 2024. https://www.psychiatrictimes.com/view/slow-release-oral-ketamine-formulations-show-promise-for-at-home-treatment-of-resistant-depression
4. NRx Prescription drugs, Inc. (NASDAQ:NRXP) information preliminary part of U.S. New Drug Software to the FDA for NRX-100 (IV ketamine) for the remedy of suicidal despair. Information launch. December 30, 2024. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-files-initial-section-of-us-new-drug-application-to-the-fda-for-nrx-100-iv-ketamine-for-the-treatment-of-suicidal-depression-302340035.html
