June 12 An advisory committee to the U.S. Food
and Drug Administration recommended on Thursday that the agency
not require large cardiovascular safety trials for a class of
drugs used to treat opioid-induced chronic constipation.
Initially 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.
In a post-vote discussion, several panelists said they
misunderstood the question and would have voted against the need
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.
(Reporting by Toni Clarke in Washington; Editing by Eric Beech)