The US FDA has agreed to lift the clinical hold on ocinaplon, DOV Pharmaceutical Inc's novel anxiolytic, subject to its review of a revised clinical trial protocol that among other things includes more frequent liver enzyme testing. The Company intends to submit such revised protocol shortly and expects to commence this pivotal clinical trial in 2004, a company release said.

On October 2, 2003, the FDA placed the start of the Company's phase III pivotal clinical trial of ocinaplon on hold and requested that the Company provide additional safety information. The Company submitted information to the FDA, including a revised protocol, and requested that the clinical hold be lifted.

The FDA will allow, subject to further protocol review, DOV to proceed with a 28-day, multi-centre, randomized, placebo-controlled, double-blind, efficacy and safety clinical trial in which up to 270 patients with generalized anxiety disorder will receive a maximum daily dose of 60mg of ocinaplon compared to 90 patients who will receive placebo. The required revisions to the submitted protocol primarily include strengthened safety measures, including ones proposed by the Company, to more closely monitor potential instances of abnormal liver enzyme elevations.

"We are extremely pleased with the FDA's decision. Our team worked hard to provide the agency with the requested safety data in a timely fashion and we are eager to move forward with the clinical development of ocinaplon," said Dr Arnold Lippa, president and CEO.

DOV is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular and urological, that involve alterations in neuronal processing. The Company has six product candidates in clinical trials addressing therapeutic indications with significant unmet needs.