Acura and King Pharmaceuticals have announced that FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox Tablets CII. Its an immediate release product intended for the relief of moderate-to-severe pain.
The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox. Acura and King Pharmaceuticals are currently evaluating the Letter and believe that they can respond to the issues raised without conducting any additional studies. The companies plan to meet with the FDA following submission of their response.
Acurox is a 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. Acurox utilizes Acura’s proprietary Aversion technology. The Acurox Tablets NDA was originally accepted for filing by FDA earlier this year, with a priority review classification.