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 (71) | 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 (184) | 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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