The company is seeking FDA approval of an IV ketamine treatment for acute depression and suicidality.
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NRx Pharmaceuticals, a clinical-stage biopharmaceutical firm, recently told investors that it plans to spin off a ketamine-focused company.
The spinoff company “would potentially provide current and new investors with both capital appreciation and a royalty stream,” NRx said in a news release.
“A term sheet for up to $30 million in anchor financing for a new public entity has been presented to management by a capable investor and a structure whereby a portion of the equity in the ketamine asset will be allocated to existing shareholders,” the company said, adding that the proposal will be discussed at the upcoming annual shareholder meeting.
Radnor, Pennsylvania-based NRx is seeking FDA new-drug approval for NRX-100, an intravenous ketamine treatment for acute depression and suicidality.
In October, the company announced “a strategic acceleration of its plans to develop a commercial form of NRX-100,” citing the results of a major ketamine study in France; the failure of nasal ketamine to reduce suicidal ideation and depression in a long-awaited trial; and FDA warnings on the risks of compounded ketamine products, including nasal spray and oral formulations.
“Although NRx has long held the belief that ketamine is not suitable as a long-term treatment for depression and suicidality because of its potential for neurotoxicity, addiction and hallucination, we have long-recognized ketamine’s unique ability to provide rapid remission from acute suicidality, provided a safe, oral drug can be implemented to maintain the life-saving effect,” the company said in October.
“With the availability of what are now two clinical trials that demonstrate clinically meaningful and statistically significant benefit of ketamine vs. both placebo and midazolam (active comparator), we hope that a path to accelerated approval of NRX-100 (IV ketamine) as an agent for rapid reversal of suicidality as a prelude to long-term oral therapy can be identified.”
Earlier this month, NRx announced a joint agreement with Nephron Pharmaceuticals to manufacture a presentation of ketamine suitable for treating suicidal depression. Nephron is a South Carolina-based manufacturer of sterile injectable drugs.
In its recently announced third-quarter financial results, NRx said it expects to submit a new-drug application in first-quarter 2024, with a targeted PDUFA date in fourth-quarter 2024.