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what is the current status of Ocinaplon?

Posted by krybrahaha78 on April 21, 2006, at 0:41:18

In reply to Ocinaplon details, posted by jclint on November 25, 2004, at 15:57:24

Is this drug still coming out?

> Just found this in a news article, thought it might interest some people.
>
> "Ocinaplon is DOV's product candidate for the treatment of anxiety disorders, including GAD, the first indication for which the Company intends to seek FDA approval. Anxiety can be defined in broad terms as a state of unwarranted or inappropriate worry, often accompanied by restlessness, tension, distraction, irritability and sleep disturbances and is made up of various disorders, including GAD, panic disorder and phobias. GAD is the most common of the anxiety disorders, with a lifetime prevalence of approximately 5%. Every year, it is estimated that approximately 15 million people in the U.S. suffer solely from an anxiety disorder.
>
> The Company believes ocinaplon, a non-benzodiazepine, can address significant unmet needs for the treatment of anxiety disorders. Ocinaplon appears to selectively modulate a specific subset of GABAA receptors that DOV believes are involved in the mediation of anxiety. Preclinical studies have demonstrated that ocinaplon produces an anti-anxiety effect at doses 20 to 40 times lower than doses that produce sedation and muscle relaxation and 10 times lower than doses that produce amnesia. In preclinical studies, ocinaplon was also shown to be 15 times less likely than Valium to potentiate the sedating effects of alcohol. By contrast, benzodiazepines often produce these side effects at doses approximating those that produce an anti-anxiety effect.
>
> To date, 11 clinical trials on ocinaplon have been conducted, including nine Phase I trials. In these clinical trials, ocinaplon was shown to be safe and well-tolerated at the maximum doses used, with no evidence of sedation or any other side effects typically associated with benzodiazepines. To date, 477 subjects have been treated with ocinaplon.
>
> In DOV's two Phase II double-blind, placebo-controlled clinical trials, ocinaplon exhibited the following characteristics:
>
> -- efficacy at least comparable to what has been reported for
> benzodiazepines;
>
> -- rapid onset of action;
>
> -- a favorable side effect profile not significantly different from
> placebo; and
>
> -- no "rebound" anxiety following treatment cessation."
>
>


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poster:krybrahaha78 thread:419216
URL: http://www.dr-bob.org/babble/20060417/msgs/635442.html