Acura Pharmaceuticals (Acura) and King Pharmaceuticals (King) have met with the FDA on September 2, 2009 to discuss the agency’s Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HCl and niacin) Tablets CII.
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.
Reportedly, FDA and both the companies agreed to take the application to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox Tablets.
Moreover, FDA indicated that no new clinical trials are required at this time. The agency has not yet set a meeting date for the Advisory Committee’s review of the NDA.