FDA accepts King's ACUROX NDA for filing with Priority review classification

Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King's New Drug Application (NDA) for ACUROX^® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) with a Priority review classification and a Prescription Drug User Fee Act (PDUFA) date of June 17, 2011. In addition to filing acceptance and assignment of a Priority review classification, the FDA's filing communication letter to King also includes preliminary comments about potential review issues relating to an intranasal abuse liability study included in the NDA and requests additional information relating to this study and other issues. The preliminary notice of potential review issues is not indicative of deficiencies that may be identified during the FDA's review of the NDA. No assurance can be given that any issues raised as part of the FDA's review of the ACUROX^® NDA (including the potential review issues in the FDA's filing communication letter) will be addressed to the FDA's satisfaction or that the ACUROX^® NDA will be approved by the FDA.

SOURCE Acura Pharmaceuticals, Inc.