Acura Pharmaceuticals, Inc and King Pharmaceuticals, Inc announced that Acura has submitted a New Drug Application (NDA) for Acurox (oxycodone HCl/niacin) tablets to the US Food and Drug Administration (FDA) including a request for priority review. The FDA is expected to determine whether to accept the 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. According to the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration in 2006, immediate-release opioids are abused 10 times more frequently than extended-release opioids.
Acurox, a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient, has a proposed indication for the relief of moderate to severe pain. 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.
Aversion Technology is a patented composition of active and inactive ingredients intended to relieve moderate to severe pain and deter common methods of prescription drug abuse, including intravenous injection of dissolved tablets, nasal snorting of crushed tablets, and intentional swallowing of excess numbers of tablets.
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in research, development and manufacture of innovative Aversion (abuse deterrent) Technology and related product candidates.