FDA to lift hold on ocinaplon

DOV Pharmaceuticals (DOVP) said FDA has agreed to lift a clinical hold on the company's Phase III trial of its controlled-release ocinaplon to treat generalized anxiety disorder (GAD), subject to the review of a revised clinical trial protocol. The revised protocol will include more frequent liver enzyme testing and safety measures that more closely monitor potential instances of abnormal liver enzyme elevations. DOVP expects to submit the revised protocol and start clinical trials this year. Last October, FDA placed the start of the trial on hold pending additional safety data. Ocinaplon is a modulator of a specific subset of GABA A receptors. ...