The user fee goal date under the Prescription Drug User Fee Act is June 30, 2009. The FDA may grant a new drug application 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.
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.