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
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[SINGAPORE] iX Biopharma is clearing the path for its sublingual ketamine wafer to treat military casualties after the US officially opened a rare emergency regulatory route for battlefield pain medications, the company said on Monday (Sep 7).
The move, triggered by a declaration published on Sep 3 after determinations by the US government, allows the Food and Drug Administration (FDA) to consider Emergency Use Authorization (EUA) for the drug, known as Wafermine.
Catalist-listed iX Biopharma said it expects to complete its EUA submission to the FDA in the fourth quarter of 2026.
An emergency approval would enable the company to deploy Wafermine to US armed forces ahead of full FDA approval, unlocking commercial revenue early while phase three clinical trials proceed in parallel.
The speciality drugmaker in February secured a US$41 million sole-source contract from the US government to fund development and the regulatory push.
“No company can bring about a declaration of this kind; it requires the US government to act and declarations under this pathway are extremely rare,” iX Biopharma chairman and CEO Eddy Lee said.
“Our focus now is completing the EUA submission and getting Wafermine to US military personnel urgently.”
The company noted that the US Federal Register records show that the only previous declaration under Section 564 of the US Federal Food, Drug and Cosmetic Act for military needs occurred more than six years ago. This was for freeze-dried plasma used to treat combat haemorrhages.
The determination stemmed from military findings that combat attacks pose heightened risks of severe pain, shock and life-threatening hemodynamic instability.
Without the new declaration, supplying Wafermine to combat personnel would have required waiting for full FDA market approval.
Shares of iX Biopharma rose 2.2 per cent to close S$0.01 higher at S$0.475 on Thursday, before it called for a trading halt on Friday. The trading halt was lifted on Monday before market open, alongside the announcement.
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