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 Seven panelists voted in favor of such trials for all drugs, five
voted in favor of trials for select products and 12 voted against
the need for trials. But in a post-vote discussion, several
panelists said they misunderstood the question and would have voted
against the need for such trials.
The drugs, known as peripherally acting mu opioid receptor
antagonists, include Salix Pharmaceuticals Ltd's Relistor, also
known as methylnaltrexone, and Cubist Pharmaceuticals Inc's Entereg,
also known as alvimopan.
AstraZeneca Plc and Nektar Therapeutics also have a product,
naloxegol, in development. Constipation is a common side effect of
opioid painkillers such as morphine.
The panel met to discuss the matter because one of several
late-stage studies of Entereg found a greater number of heart
attacks in patients taking that drug. The FDA nonetheless approved
it for short-term use because other trials did not show a similar
cardiovascular safety signal.
Most of the panelists said they thought there could be a weak safety
signal associated with the drugs but that they did not have enough
information to make a definitive assessment.
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While they did not recommend that companies be required to conduct
large, randomized, controlled trials prior to approval, which would
be expensive, time-consuming and complex, they did recommend studies
be conducted to monitor for safety after the drugs reach the market.
(Reporting by Toni Clarke in Washington; Editing by Eric Beech and
Will Dunham)
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