DOV bicifadine NDA in first half of 2007
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
DOV will perform a human QT study for its non-opioid analgesic prior to its planned NDA submission in the first half of 2007, the firm says Feb 12. The company is conducting the study "as it appears this is an emerging standard for all new molecular entities," and not due to safety issues with the agent. "To date, there have been no electrocardiogram - or other - safety concerns in DOV's preclinical studies or in clinical studies involving more than 2,500 subjects treated with bicifadine," DOV maintains. The initial bicifadine NDA will support use in chronic low back pain. DOV recently discontinued development of its GABA receptor antagonist ocinaplon for generalized anxiety disorder (1Pharmaceutical Approvals Monthly November 2005, In Brief); other projects include triple-uptake inhibitors, in development with partner Merck for depression...