RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced that it will present a keynote address at the highly anticipated Sachs Neuroscience Innovation Forum in San Francisco later today.
The address, entitled “Ketamine for Suicidal Depression: The Benefits are Clear, But So are the Risks,” will provide an in-depth exploration of ketamine’s potential as a treatment for suicidal depression. The presentation comes as NRx prepares to file a New Drug Application for ketamine in 2024, both in the United States and the European Union, in partnership with the Fondation FundaMental based in Paris.
The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to NRx in 2017 to develop ketamine as a life-saving drug for suicidal depression. Initial evidence of efficacy came from small clinical trials, but according to Jonathan Javitt, MD, MPH, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, the drug’s impact was so dramatic that it became a standard of care ahead of larger clinical trials required for approval.
Javitt revealed that recent large-scale trials have confirmed ketamine’s superiority over placebo and its comparability, and in some cases superiority, to electroshock therapy (ECT). However, he highlighted the challenges posed by the current formulation of ketamine, which is designed for use in human and veterinary anesthesia and requires local pharmacy compounding for clinical use—a practice the FDA has cautioned against.
To address this issue, NRx is partnering with Nephron Pharmaceuticals to develop a modern, single-use, diversion- and tamper-resistant formulation of ketamine. In addition, they are collaborating with psychiatry leaders in the U.S. and Europe to devise a Risk Evaluation and Mitigation Strategy (REMS) program for ketamine, which will include training for providers on safe and proper use.
NRx has also announced the creation of HOPE Therapeutics, Inc. to advance its drug development of ketamine. Existing shareholders and new investors are set to be awarded rights in HOPE.
The keynote address will be simulcast, with details available on the company’s website. A question-and-answer session moderated by Bob “Sully” Sullivan of Biz Talk will follow the presentation, allowing for further exploration of this groundbreaking treatment strategy.
As NRx forges ahead with its plans for ketamine, it’s clear that the pharmaceutical industry is on the cusp of a potential game-changer in the battle against suicidal depression.
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