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Ketamine Wafer Slated For Study in Phase 3 Trials
iX Biopharma Ltd has successfully concluded an End-of-Phase 2 meeting with the FDA regarding Wafermine, a sublingual ketamine wafer for the treatment of acute moderate to severe pain.
Ketamine is an NMDA antagonist which, unlike opioids, does not cause respiratory depression leading to death if misused. Wafermine has the potential to be used in substitution or as an adjunct to opioids, addressing a large unmet clinical need.
The two parties reached agreement on key aspects of the pivotal phase 3 clinical trial program to support approval of Wafermine for the indication of acute moderate to severe pain. The phase 3 program consists of two randomized, double blind, placebo-controlled studies, one in an orthopedic pain model (bunionectomy) and one in a soft-tissue pain model (abdominoplasty or "tummy tucks"). Both of these postoperative pain models were successfully evaluated in the recent phase 2b clinical study.
Source: iX Biopharma, Dec. 11, 2019