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Phase III Trial of Ocinaplon Placed on Hold by FDA
HACKENSACK, N.J., Oct. 2 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced that today the Food and Drug Administration placed the start of the Phase III pivotal trial of ocinaplon, DOV's novel anti-anxiety product candidate, on hold. The FDA has requested that DOV produce additional safety information satisfactory to the agency in order to remove the hold and permit DOV to commence the trial. The company intends to diligently assemble the necessary information in accordance with FDA comments and communicate further with the FDA as soon as reasonably practicable.
Source: DOV Pharmaceutical, Inc.