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Phase 3 Protocol for Oxymorphone Approved
"We are pleased by the FDA's decision, which clears the way for us to begin enrolling patients in this clinical trial," said Carol A. Ammon, chairman and chief executive officer. "We now believe we will be in a position to file our complete response to the FDA's approvable letter for oxymorphone ER in early 2006."
Under the terms of the SPA, Endo will conduct a 12-week, multicenter, double-blinded, placebo-controlled Phase III trial of oxymorphone ER in patients who have had no prior or recent treatment with opioid analgesics.
Source: Endo Pharmaceuticals, Inc.