Ad Comm recommendation bodes well for opioid-induced constipation drugs

|By:, SA News Editor

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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