- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee recommends the FDA not require large clinical trials to assess the cardiovascular risk of the class of drugs to treat opioid-induced constipation.
- Initially, seven members voted for the need for the trials, five voted in favor of trials for select products and twelve voted against the need for the trials. In a post-vote discussion, several members stated that they misunderstood the question and would have voted against the need for the trials.
- The recommendation, if adopted by the FDA, would potentially mitigate a time-consuming and expensive hurdle for the drug makers in their NDA application efforts.
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