The FDA is expected to determine whether to accept the new drug application (NDA) for filing and consider the priority review request within 60 days. If approved, Acura and King believe Acurox will be the first FDA approved immediate release opioid analgesic designed to deter swallowing excess quantities of tablets and other common methods of misuse and abuse.
Acura said that the NDA submission for Acurox tablets includes positive results from a pivotal Phase III clinical efficacy and safety study conducted pursuant to an FDA agreed special protocol assessment with statistically significant primary efficacy endpoints; three clinical studies assessing the abuse-liability potential of Acurox, demonstrating with statistical significance that subjects with a history of opioid abuse disliked Acurox compared to immediate release oxycodone HCl alone when snorting crushed tablets or swallowing excess numbers of tablets; and two laboratory studies assessing the difficulty of intravenously injecting the oxycodone active opioid ingredient contained in Acurox tablets.
Acurox utilizes Acura’s patented Aversion technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets.