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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 4 of 4. This is the beginning of the thread.
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.
Posted by linkadge on August 27, 2005, at 9:48:17
In reply to phase III anxiety trial for Ocinaplon's on hold, posted by aabag on August 25, 2005, at 23:14:38
What is the mechanism of this drug ??
Linkadge
Posted by Tom Twilight on August 28, 2005, at 5:55:17
In reply to phase III anxiety trial for Ocinaplon's on hold, 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.
The reason for the hold, a patient with elevated liver enzymes.
>
This is very frustrating, I'm suprised there hasn't been more of a reaction to this on babble
Unfortunatly after Viox drug companies are going to be extremely cautious about safetyIn my opinion companiesare probably going to be overly cautious, lots of valuable medications like Nardil would never have seen the light of day with todays safety standards.
In answer to Linkadges question: Oncinaplon is supposed to have the anti anxiety effect of Benzo's without the potential for deppendence, or sedation.
It binds selectivly to the GABA A receptors responsible for anxiety, I think
I'm probably wrong!
Posted by aabag on August 28, 2005, at 12:46:39
In reply to Re: phase III anxiety trial for Ocinaplon's on hold, posted by Tom Twilight on August 28, 2005, at 5:55:17
That's right, Tom. There are a number of GABA-A receptor subtypes, some of which are responsible for sediation, anxiolysis (reduction of anxiety), muscle coordination, and amnesia. Ocinaplon (selective GABA-A agonist) works on the receptor subtype which "governs" anxiolysis and muscle coordination. Furthermore, the dependence issue is not present, in the trials I've looked at. With the current crop of benzos, dependence, short-term memory loss, and sediation are problems, to varying degrees and with varying individuals (I should know). Ocinaplon's claim to fame would be as a pure anxiolytic.
This is the end of the thread.
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