FDA accepts opioid therapy

Published: 24-Feb-2003


The FDA has accepted for filing Endo Pharmaceuticals' New Drug Application (NDA) for oxymorphone extended release tablets (oxymorphone ER). Oxymorphone ER is an oral extended-release opioid analgesic that was jointly developed with PenWest Pharmaceuticals for the treatment of moderate to severe pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time.

As previously disclosed, Endo submitted the NDA for oxymorphone ER on December 19, 2002. "We are very pleased with the FDA acceptance of the NDA for oxymorphone ER and look forward to bringing this important new pain product to the market. We believe oxymorphone ER will offer physicians and their patients an important new option for managing chronic pain, and will contribute significantly to the approximately US$2bn (€1.8bn]) market for long-acting oral opioids.

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