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Ventrus' Diltiazem improves symptoms but doesn't beat placebo

  • Ventrus Biosciences' (VTUS) Diltiazem Cream to treat patients with anal fissures improved their symptoms in a second Phase III trial, as expected.
  • However, the placebo effect in the control group was greater than anticipated, resulting in no significant difference between the treatments.
  • In the first pivotal Phase 3 trial, Diltiazem did perform better than the placebo.
  • Ventrus plans to request a pre-NDA meeting with the FDA to determine its next steps. (PR)
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Comments (3)
  • teamcarrot
    , contributor
    Comment (1) | Send Message
     
    Fail!
    12 Feb 2014, 09:03 AM Reply Like
  • drive-by poster
    , contributor
    Comments (24) | Send Message
     
    "the placebo effect in the control group was greater than anticipated" -- what, people with this issue were just glad someone was doing something for them?
    12 Feb 2014, 09:57 PM Reply Like
  • seviay
    , contributor
    Comments (161) | Send Message
     
    "the placebo effect in the control group was greater than anticipated" -- perhaps the anus responds well to any kind of rubbing LOL
    14 Feb 2014, 01:26 AM Reply Like
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