Our study AP-ADF-105 is titled “A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acurox™ (oxycodone HCl and niacin) Tablets versus Placebo for the Treatment of Acute, Moderate to Severe Postoperative Pain Following Bunionectomy Surgery in Adult Patients.”  Patient enrollment in this study is now complete and Top-line results are anticipated in July 2008. The study enrolled approximate 405 patients with moderate to severe pain following bunionectomy surgery.  The primary endpoint is a reduction in the sum of the pain intensity difference for 48 hours (SPID 48) for active drugs versus placebo. We submitted the study protocol to the FDA and requested and received agreement for a Special Protocol Assessment ("SPA").  Clinical protocols for Phase III trials whose data will form the primary basis for an efficacy claim are eligible for a SPA.  A SPA from the FDA is an agreement that the Phase III trial protocol design, clinical endpoints, and statistical analyses plan are acceptable to support regulatory approval and is binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun. 

We expect to submit a 505(b)(2) NDA for Acurox™ Tablets before end of 2008.