Massachusetts, USA-based Javelin Pharmaceuticals says it has begun patient dosing in a Phase III trial of its cancer pain medication PMI-150 (intranasal ketamine). The study, which is being conducted at the Beth Israel Deaconess Medical Center, in Boston, is expected to enroll 90 patients and is designed to confirm the promising results seen in a pilot study.
Additionally, Javelin said that it has begun to prepare a New Drug Application seeking Food and Drug Administration approval for the product as an emergency analgesic, in preparation for a planned submission in 2008.
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