FDA panel advises against large opioid-constipation drug trials
June 12 (Reuters) - 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 for 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. (Reporting by Toni Clarke in Washington; Editing by Eric Beech)