Clinical Trial

Endo Pharmaceuticals announces agreement for Oxymorphone ER trial design

Published in Medical Letter on the CDC and FDA, August 8th, 2004

Penwest Pharmaceuticals Co. (NASDAQ:PPCO) announced that its development partner Endo Pharmaceuticals Holdings Inc. has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a new clinical trial for oxymorphine extended release tablets.

The clinical trial is designed to provide additional safety and efficacy data for oxymorphone extended-release tablets (oxymorphone ER) to support Endo's New Drug Application (NDA) for this developmental product.

Endo, which jointly developed oxymorphone ER with Penwest, said it had submitted the trial protocol to the FDA under the Special Protocol Assessment (SPA) process. Under the...

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Source: Medical Letter on the CDC and FDA (2004-08-08)

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