FDA: Embeda could carry abuse risk

FDA staffers have expressed concern that Alpharma's powerful painkiller Embeda could be abused even though the company designed the drug not to be. Embeda contains morphine sulfate and Duramorph. Alpharma designed the med to be effective when taken as directed, but to be abuse-resistant if used orally. The FDA, however, says the drug could still be crushed and injected by addicts.

"[I]t is unknown what the potential effects of injecting this product following manipulation," wrote the FDA. "Since [Alpharma] only tested the effects of manipulation orally, we recommend consideration be given during evaluation of the application as to whether these known methods of misuse and abuse are impacted by the abuse deterrents in Embeda."

Embeda will be reviewed by an outside panel of experts Friday. Cowen and Co. analyst Ian Sanderson said he expects the drug to be approved, but that the FDA may be looking for labeling advice and a risk management program.

- see this report [1] for more

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