UPDATE 1-FDA panel advises against large opioid-constipation drug safety trials

June 12, 2014 5:07 PM

6 0

WASHINGTON, 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.

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.

Read more

To category page

Loading...