Alpharma has withdrawn its NDA for Embeda, its extended-release painkiller. While the company's drug qualified for priority review, Alpharma said that "certain technical issues around data presentation" prevented the FDA from evaluating the drug in the six month review time. There were no details on exactly what those technical issues were. Alpharma said it plans to quickly resolve the issues, re-submit the NDA and launch the drug in the first quarter of 2009.
In its most recent Phase III trial, Embeda demonstrated significant pain relief. The painkiller is designed to be effective when taken as directed, but if tampered with by a drug abuser, the feeling of euphoria is dampened.
- see Alpharma's release
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