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news.King Pharmaceuticals Research and Development’s new drug application (NDA) for ACUROX (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA).
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The filing was accompanied by a priority review classification and a Prescription Drug User Fee Act (PDUFA) date of 17June, 2011.
Apart from filing acceptance and assignment of a Priority review classification, the FDA’s filing communication letter to King includes preliminary comments on potential review issues relating to an intranasal abuse liability study included in the NDA. It also requests additional information relating to this study and other issues.
The preliminary notice of potential review issues does not indicate any deficiencies that may come to the fore during the FDA’s review of the NDA.
ACUROX is a patented, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient.
ACUROX is intended for oral administration with a targeted indication for the relief of moderate to severe pain.
ACUROX Tablets utilize Acura Pharmaceuticals’ patented Aversion Technology which is designed to limit or impede opioid abuse via intravenous injection of dissolved tablets and nasal snorting of crushed tablets.
Acura entered into a license, development and commercialization agreement with King (a wholly owned subsidiary of King Pharmaceuticals) in October 2007 pursuant to which Acura and King would jointly develop ACUROX Tablets (with and without niacin) and three additional opioid analgesic product candidates utilizing Aversion Technology.