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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...

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DOV drops ocinaplon

DOV is discontinuing development of its GABA receptor agonist ocinaplon "due to an unacceptable rate of liver enzyme elevations," the firm says Oct. 28. Ocinaplon, which had been in development for generalized anxiety disorder, had experienced several clinical holds, the most recent occurring in August (1Pharmaceutical Approvals Monthly September 2005, p. 15). "DOV will select a follow-on candidate from one of the backup compounds in its preclinical program," the company says. The firm also confirmed plans to submit an NDA for use of its non-opioid analgesic bicifadine in chronic low back pain during the first half of 2007. Phase II studies in osteoarthritis and neuropathic pain are slated to begin in the fourth quarter of 2005; an acute pain sNDA is slated for the fourth quarter of 2007...

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