DOV PHARMACEUTICAL PLACES PHASE III CLINICAL TRIAL ON HOLD
DOV Pharmaceutical has suspended further dosing in its ongoing Phase III clinical trial of ocinaplon, its novel anti-anxiety agent. This double-blind study had been intended to treat up to 373 healthy subjects and patients with generalized anxiety disorder with 60 mg/day of ocinaplon or placebo for four weeks. Approximately 200 subjects and patients have been randomized for treatment.
The recent occurrence of enzyme elevations in liver function tests (LFTs) for one subject in this trial were of sufficient concern that DOV, in consultation with the independent data monitoring committee, decided to suspend the trial. This will enable DOV to unblind the study results and fully evaluate the safety findings from all subjects in the clinical trial. The data from the one subject could represent a consistent adverse effect of the study drug. Several other subjects had elevations of LFTs but not to a degree sufficient to stop dosing.
DOV will continue to monitor the subjects and patients currently enrolled in the trial and, upon full analysis and completion of its review, make a decision to continue with ocinaplon or select a back-up compound.