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Published on 8 May 2008

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Painkiller “too strong for market”

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A powerful painkiller is unlikely to be marketed for uses beyond treating pain in cancer patients after a panel of medical experts voted against the move in the US.

Experts from the US Food and Drug Administration (FDA) said the plan could worsen existing misuse of Fentora, made by Cephalon, which has caused overdoses and deaths.

Fentora is approved to treat severe pain in cancer patients who are already taking opioids, a type of prescription painkiller.

The company wanted the FDA to approve it for the broader market of other chronic pain, such as back and nerve pain.

The FDA panel of outside experts voted 17 to three against wider use of the drug, questioning the need for such powerful medication for non-cancer patients, when strong drugs were already on the market.

The agency is not required to follow advice from the panel, though it usually does.

Panel member Dr Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh, said: “How many people are we going to help with the release of this product and how many are we going to hurt? In my mind it is very scary to release such a large amount of powerful opiate into the American population.”

Copyright © PA Business 2008

Cephalon



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