I can't help it - every time some slight mention of this comes past my feedreader, I begin salivating helplessly, and I don't even like ketamine all that much. But still... you may remember a while back when we reported that Javelin Pharm was headed toward clinical trials in humans of an intranasal ketamine treatment. Well... the only new thing to report is that they finally got around to dosing their first patient in this study:
Javelin Pharmaceuticals announced dosing of the first patient in a Phase III clinical study of intranasal ketamine for the treatment of breakthrough cancer pain.
Javelin said it has begun to prepare its new drug application (NDA) for an initial indication as an emergency analgesic, and plans to submit it to the FDA in 2008. A later, supplemental NDA is planned for the indication of breakthrough cancer pain, the company added....
The primary measure of efficacy is the sum of the differences from initial pain intensity as measured on a zero-10 scale during the first 60 minutes after dosing, the company added.
It's so incredibly difficult to just be objective about the fact that this substance, delivered in this fashion, could produce real relief for cancer patients in pain, when it could also produce incredibly warm fuzzies for strung out ravers coming down from massive doses of street E. And yet, I will soldier on...
