Alpharma's Embeda has improved abuse profile, US panel says

Tuesday 18 November 2008
Sue Sutter - Washington Editor

Alpharma's Embeda (ALO-01), a modified-release formulation of morphine coupled with the opioid antagonist naltrexone, is an incremental improvement over existing morphine products because it appears to be less susceptible to abuse and misuse, the FDA's anaesthetic and life support drugs and drug safety/risk management advisory panels said on November 14th.

Using terms such as "small advance" and "marginal" benefit, most panellists agreed Embeda would be less attractive to drug abusers because when the capsule is crushed, the euphoric effects of the released morphine are blunted by naltrexone. Crushing is the most common means for defeating the controlled-release mechanisms of currently available morphine products, causing all of the active ingredient to be immediately released. However, the panel said more data were needed on potential abuse through intravenous injection, snorting and chewing, and individuals intent on defeating the formulation's protections will invariably find a way to do so.

Labelling for Embeda should explain that naltrexone is released if the capsule is crushed or chewed, potentially resulting in a lack of efficacy and withdrawal symptoms, the committee said...


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