Anesiva: FDA requests new trial for needle-free anesthetic prior to approval

By Elaine Rigoli

Tampa, Fla., July 12 - Anesiva, Inc. said Wednesday that during a pre-filing meeting, the Food and Drug Administration said an additional phase 3 trial in adults will be needed to seek a broader product label for 3268, the company's needle-free, local anesthetic that has been shown to reduce pain associated with blood draws and intravenous placements.

This trial, which should take less than six months to complete, is expected to begin in the fourth quarter of this year.

After the meeting, which covered clinical, preclinical and manufacturing aspects of the drug, the company said it will file a New Drug Application by October for 3268, and the NDA will be filed as a common technical document, which can be accepted for review under both domestic and international guidelines.

If approved, 3268 could be launched in 2007 for the pediatric population.

The company said 3268 demonstrated statistically significant pain reduction in two phase 3 clinical trials in children, which will form the basis of the initial NDA filing.

Anesiva, formerly Corgentech, is a late-stage biopharmaceutical company based in South San Francisco, Calif.

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