Acura Pharmaceuticals, Inc and King Pharmaceuticals, Inc announced that Acura's New Drug Application (NDA) for Acurox (oxycodone HCl/niacin) tablets was accepted for filing by the US Food and Drug Administration (FDA) with a priority review classification. Acurox is an immediate release opioid analgesic, has a proposed indication for relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse.
The user fee goal date under the Prescription Drug User Fee Act (PDUFA) is June 30, 2009. The FDA's timelines described in the PDUFA guidance are flexible and subject to change based on workload and other potential review issues.
The FDA may grant an NDA a priority review classification if its assessment of conditions and information available at the time the application is filed indicates the drug product has the potential to provide, among other things, significant improvements compared to marketed products. A priority review classification by the FDA determines an NDA's review timeline under PDUFA and is not intended to predict a drug's market acceptance or sales potential. If the Acurox Tablets NDA is ultimately approved by FDA, for which no assurances can be provided, the companies believe Acurox Tablets will be the first approved immediate release opioid analgesic designed to deter the most common methods of opioid 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 were abused approximately 10 times more frequently than extended-release opioids.
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.
Acura Pharma is a specialty pharmaceutical company engaged in research, development and manufacture of innovative Aversion (abuse deterrent) Technology and related product candidates.