Endo Pharmaceuticals Inc, a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc announced that the New Drug Applications (NDAs) for its oxymorphone extended release tablets (oxymorphone ER) and immediate release tablets (oxymorphone IR) have both been accepted for filing by the U.S. Food and Drug Administration. As previously disclosed, Endo submitted the NDAs for oxymorphone ER and IR on December 19 and 20, 2002, respectively.

Endo is developing oxymorphone ER, an oral extended release opioid analgesic, with Penwest Pharmaceuticals Co. for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time. Endo is developing oxymorphone IR, an oral immediate release opioid analgesic complement, for the management of moderate-to-severe pain where the use of an opioid is appropriate.

"The FDA's acceptance of these NDAs, the first since Endo was formed in 1997, is a major milestone for our company. We believe we are building on our track record of success to create a foundation of sustainable growth," said Carol A. Ammon, chairman and chief executive officer. "We feel oxymorphone ER, with twice-daily dosing, and oxymorphone IR will be important new pain management options for physicians and their patients, and we look forward to working with the FDA to bring these products to market." She added that under the performance goals established by the prescription drug user fee program, Endo expects the FDA to act on the applications by the end of 2003.