Ad Comm recommendation bodes well for opioid-induced constipation drugs

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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Comments (2)
  • T-time
    , contributor
    Comments (991) | Send Message
    Will the FDA swallow their pride and approve it or will this be a test of ego? Anyone have any feelings on this?
    12 Jun 2014, 04:24 PM Reply Like
  • Scrying Biotech
    , contributor
    Comments (2819) | Send Message
    No pride to swallow. The FDA has already admitted their mistake on pre-approval CVOT testing. This outcome confirms AstraZenca's position on the matter and September 16th will prove this to be true.


    Records will need to be kept relative to CV events for a 5 year post approval period. All new OIC drugs will need the same 12-month safety study Nektar employed with an emphasis on vulnerable patient populations.
    12 Jun 2014, 07:34 PM Reply Like
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