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Endo oxymorphone ER "complete response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Endo submits a complete response to FDA's 2003 "approvable" letter for its extended-release oxymorphone, the firm announces Dec. 22. Per FDA's request, Endo studied two distinct groups of patients with chronic low back pain: opioid-naïve and opioid-experienced. Endo also submitted trial data regarding its immediate-release oxymorphone product, which is also approvable. The IR data includes Phase III data from a trial in patients with post-operative pain. The submission "will supplement the previously submitted Phase III trials for both products that the company believes the FDA already has accepted as demonstrating efficacy in the intended patient populations," Endo says. The company is preparing to launch oxymorphone ER in the second half of 2006...
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