Posted by aabag on August 25, 2005, at 23:14:38
Just got the news, DOV's anxiolytic Ocinaplon was placed on hold, by the company, not the FDA. This is significant, because hopefully Dov can determine whether this issue is somebody eating excess cheeseburgers, or a genuine hepatic problem. The reason for the hold, a patient with elevated liver enzymes.
I don't mean to make light of this, but Mogan Spurlock, of "Supersize Me" fame, would have caused the Ocinaplon trial to fail, since, as you may recall, his liver enzymes, on a strict McDonalds diet, bore signs of liver disease (elevated liver enzymes). As you can tell, I'm bitter.
Next steps, from the press release, indicate an unblinding the trial so that DOV scientists can analyze the data and determine if the elevation was an "outlier" as they put it, or whether its representative of the drug.
I am disappointed. Ocinaplon has a novel mechanism an action discovered nearly 20 years ago, and nobody has brought it, or the idea, to market. Of course, any pharmaceutical company of right mind would want an effective true anxiolytic. Dov has a backup compound, but it sure would be welcome news to hear that it was an "outlier". Dov is counting on other compounds for insomnia and pain, but for those of us with social anxiety, this news is painful enough.
poster:aabag
thread:546772
URL: http://www.dr-bob.org/babble/20050821/msgs/546772.html