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Zalicus AŞ Message Board

  • scistats scistats Apr 6, 2013 5:08 AM Flag

    Justin Renz's most important words:

    Corrigan’s favorite lab animal pain test is the "spinal nerve ligation (Chung) test".

    While NMED160 worked in animals, it failed to pass a phase 2 proof of concept third molar extraction study.

    The problem is, Justin Renz and Mark Corrigan insist that low bioavailability is the reason NMED160 failed in humans. However, if this is was the case, why did NMED160 work in animals? Is bioavailability not a problem in animals as well?

    When one thinks about it, It is much more likely that NMED160/Z160 simply cannot effectively block pain in higher animals, such as humans.

    The only evidence that we have otherwise comes from Justin Renz:

    In February 2013, he said the following: “In 2010, after Exalgo was approved, we decided to see if there were any formulations that Merck hadn’t tried that maybe could solve this problem [bioavailability]. We knew from a post hoc analysis, again admittedly with all the caveats, that the Merck study had some patients who had over 400ng/mL; they had analgesia.”

    This is a very encouraging statement, but there are subtle problems when one listens carefully.

    What does Justin Renz mean by: “admittedly with all the caveats”? This sounds spooky!

    What does Justin Renz mean by: “some patients had analgesia”? Ok, how many? Was this placebo effect?

    Sentiment: Strong Buy