iX Biopharma closes in on US military approval for pain drug
The company says it expects to complete its Emergency Use Authorization submission in Q4
iX Biopharma is making significant progress in securing approval for its sublingual ketamine wafer, Wafermine, to treat pain in US military personnel. The company has taken advantage of a rare emergency regulatory pathway recently opened by the US government to submit its Emergency Use Authorization (EUA) request. This pathway, triggered by a September 3 declaration, allows the FDA to consider EUA for Wafermine, enabling early deployment to US armed forces ahead of full FDA approval.
In February, iX Biopharma secured a US$41 million sole-source contract from the US government to fund development and regulatory efforts. Chairman and CEO Eddy Lee expressed excitement about completing the EUA submission and delivering Wafermine to US military personnel urgently. The company highlighted that the only previous military-related EUA declaration under Section 564 of the US Federal Food, Drug and Cosmetic Act occurred more than six years ago for freeze-dried plasma to treat combat haemorrhages.
Without this new declaration, iX Biopharma would have had to wait for full FDA market approval to supply Wafermine to combat personnel. The company's stock rose 2.2% following the announcement of the EUA declaration.
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