Javelin Pharmaceuticals Initiates Phase III Trial for Intranasal Ketamine
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 company said it plans to enroll up to 90 patients with breakthrough cancer pain from the U.S. in this randomized, multicenter, double-blind, crossover, placebo-controlled study.
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.
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