You are here

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.

Recent Headlines

Over Half of Patients Had Reduced Pain Levels of 30% or More
Spina Bifida, Cleft Lip Among Defects Caused by Antiepilectics
Study Data Indicate Drug May Provide Complete Remission in PV
Teplizumab Slows Progression to Disease by at Least Two 2 Years
Over 25% of Study Patients Showed 6–12 Months Remission
Researchers Extend Previous Data, Find Association is Reversed
First Anti-PD-1 Therapy Demonstrates Improved Overall Survival
New Test Could Prevent Short- and Long-term Complications