iX Biopharma wins US$41m U.S. DoD contract to fund Phase 3 development of non-opioid pain wafer Wafermine
Summary:
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iX Biopharma has secured a US$40.95m development contract from the U.S. Department of Defense to fund Phase 3 clinical development of Wafermine, its patented sublingual ketamine wafer for acute moderate to severe pain.
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The DoD funding, awarded via the Defense Health Agency, will also cover work needed to obtain a U.S. FDA Emergency Use Authorization for military use over an initial 36‑month period.
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The sole-source award reflects the U.S. Government’s assessment that iX Biopharma is uniquely positioned to deliver the required product within the timeline, given its proprietary WaferiX drug-delivery platform, advanced clinical data and manufacturing capabilities.
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Under the agreement, the DoD will fund labour and project costs through fixed monthly payments and cost reimbursements, supporting both near-term EUA deployment and longer-term NDA submission to the FDA.
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Wafermine, already backed by positive Phase 2b post‑operative pain data and supplied to Australian hospitals, targets unmet demand for non-opioid pain options in both battlefield and civilian settings.