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For the treatment of anxiety
In 1998, DOV licensed ocinaplon from Wyeth-Ayerst. Ocinaplon is our product candidate for the treatment of anxiety disorders, including generalized anxiety disorder, or GAD.
Through our joint venture with Elan, we have completed eight clinical trials on ocinaplon to date, including seven double-blind, placebo-controlled Phase I trials in which over 140 healthy volunteers have participated. In these trials, ocinaplon was shown to be safe and well tolerated at the maximum doses used, with no evidence of sedation or other side effects typically associated with BDZs.
In our Phase II double-blind, placebo-controlled clinical trial, ocinaplon exhibited the following characteristics:
- efficacy at least comparable to what has been reported for BDZs;
- rapid onset of action;
- a favorable side effect profile not significantly different from placebo; and
- no rebound anxiety following treatment cessation.
This Phase II clinical trial investigated the effects of an immediate release formulation of ocinaplon on 60 GAD patients. In this clinical trial, ocinaplon demonstrated a highly statistically significant reduction of anxiety during the four-week study period using a number of anxiety measurements, including the Hamilton Anxiety Scale. In addition, statistically significant effects were measured as early as one week after treatment, a much shorter period than reported results for current treatments. The incidence of side effects did not differ significantly from placebo.
In December 2001, we initiated a second Phase II clinical trial. This multicenter trial involves 200 patients and is a 14-day double-blind, placebo-controlled clinical trial designed to demonstrate the efficacy of ocinaplon in patients with GAD. In this clinical trial, we are evaluating a controlled release formulation of ocinaplon utilizing Elans proprietary technology.
We believe ocinaplon, a non-BDZ, addresses significant unmet needs for the treatment of anxiety disorders. Ocinaplon appears to selectively modulate a specific subset of GABAA receptors that we believe are involved in the mediation of anxiety.
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