King Pharmaceuticals Inc. (KG) and Acura Pharmaceuticals, Inc. (ACUR) said they met with the U.S. Food and Drug Administration on September 2, 2009 to discuss the FDA's June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox or oxycodone HCl and niacin Tablets CII. The FDA and the Companies agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox Tablets. The FDA indicated that no new clinical trials are required at this time. The Companies do not expect the meeting to be convened before the end of this year.
ACUROX is an investigational, patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate-to-severe pain.
For comments and feedback: editorial@rttnews.com