King Pharmaceuticals has submitted a briefing package to FDA addressing the issues raised in the Agency’s June 30 Complete Response Letter (CRL), related to the New Drug Application (NDA) for Acurox (oxycodone HCl/niacin) Tablets.
Acura and King Pharmaceuticals Research and Development (King) are scheduled to meet with FDA in late third quarter of 2009, to discuss the CRL and the briefing package.
Acurox is an immediate release tablet with a proposed indication for the relief of moderate-to-severe pain. Acurox incorporates Acura’s Aversion Technology and is intended to discourage product misuse and abuse.
Acura and King are developing Acurox and three additional opioid analgesic products, utilizing Aversion Technology.